RecallHawk
Class I Recall

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/

Medline Industries, LP

Summary

The FDA issued a Class I for NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, M by Medline Industries, LP. Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which ma.

Details

Source

Device Recall

External ID

Z-1718-2026

Action Date

2026-04-15

Status

Ongoing

Category

device

Product Description

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107

Lot/Code Info: Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000073035; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000075896; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000078648; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082387; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082384; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000087087; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093180; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093741; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000095735; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102248; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102694; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000105537; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000107947; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000113756; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000117610; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000118566; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000122251; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000124476; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000126969; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000131544; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000134543; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000139258; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000140972; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000141871; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000148316; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000071568; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000081594; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000078094; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000090667; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000100891; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000102756; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000106009; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000070691; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000074251; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000076643; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000079468; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000083282; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000086207; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000087266; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000090244; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000093925; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000096371; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000098671; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000104426; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000109080; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000112855; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000116425; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000116426; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000119589; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000126646; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000128838; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000130953; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000132140; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000133876; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000135397; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000139982; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000140796; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000148434; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000153838; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000157175; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000070753; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000072331; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000075946; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000080752; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000083175; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000085929; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000091637; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000091667; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000092995; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000095615; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000097091; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000102177; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000104282; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000108922; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000110250; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000085433; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000089290; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000091926; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000098742; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000100867; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000103336; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000112524; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000120251; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000123676; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000126203; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000133960; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000135744; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000140099; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000142801; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000144713; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000146930; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000149252; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000152505; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000155032; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000159209; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000163547; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000168371; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000173236; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000173695; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000177889; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000180765; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000185246; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000072395; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000073901; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000076691; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000077496; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000081475; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000088337; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000088765; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000101624; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000102812; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000103066; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000103067; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000115029; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000115033; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000118177; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000119095; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000120197; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000123747; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000125425; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000128384; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000129206; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000139424; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000146703; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000151616; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000152848; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000153236; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000156113; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000160838; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000166550; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000169399; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000174037; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000174009; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000183683; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000183682; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000183681; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000186609; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000186610; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000073135; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000074662; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000074664; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000075865; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000101553; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000103798; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000122264; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000070837; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000077023; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000093083; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000101551; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000105041; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000111469; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000123748; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000131345; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000138685; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000144169; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000149803; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000156861; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000160435; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000165962; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000170641; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000177104; Medline SKU # 60011044, UDI/DI each 10193489040449, UDI/DI case 20193489040385, Lot Number: 0000104443; Medline SKU # 60011044, UDI/DI each 10193489040449, UDI/DI case 20193489040385, Lot Number: 0000106377; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000070619; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000076571; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000080522; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000087199; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000093127; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000096425; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000097857; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000113192; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000120761; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000132347; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000138672; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000148332; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000150592; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000181532; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000183035; Medline SKU # 60011433, UDI/DI each 10193489040470, UDI/DI case 30193489040474, Lot Number: 0000084227; Medline SKU # 60011433, UDI/DI each 10193489040470, UDI/DI case 30193489040474, Lot Number: 0000101486; Medline SKU # 60012101, UDI/DI each 10193489040579, UDI/DI case 30193489040573, Lot Number: 0000082991; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000077557; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000086285; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000094509; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000113316; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000127192; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000135691; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000145671; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000152031; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000160880; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000165579; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000173427; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000177927; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000183390; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000188216; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000070185; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000073240; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000076727; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000079069; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000082697; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000086202; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000086434; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000090649; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000072816; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000077173; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000079794; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000091220; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000091833; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000095789; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000097737; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000104805; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000106258; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000114948; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000115856; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000129215; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000129501; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000131536; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000138730; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000143661; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000144820; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000145579; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000148112; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000150651; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000176144; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000188261; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000070073; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000073128; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000076474; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000078282; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000081428; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000086197; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000093782; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000096363; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000097380; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000098743; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000105137; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000106046; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000111206; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000114190; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000115831; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000118695; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000123787; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000128251; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000133072; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000138228; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000140367; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000144535; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000149547; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000152488; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000155300; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000162783; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000166461; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000168363; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000168433; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000078052; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000081986; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000096424; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000140482; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000154034; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000158778; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000172894; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000079144; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000081487; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000088809; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000093807; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000098370; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000102015; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000104687; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000107324; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000109984; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000116869; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000124230; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000129398; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000133867; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000156445; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000156915; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000160817; Medline SKU # 60013112, UDI/DI each 10193489040753, UDI/DI case 20193489040743, Lot Number: 0000110228; Medline SKU # 60013112, UDI/DI each 10193489040753, UDI/DI case 20193489040743, Lot Number: 0000112533; Medline SKU # 60013112, UDI/DI each 10193489040753, UDI/DI case 20193489040743, Lot Number: 0000161094; Medline SKU # 60018523, UDI/DI each 10193489040869, UDI/DI case 20193489040750, Lot Number: 0000112984; Medline SKU # 60018651, UDI/DI each 10193489040876, UDI/DI case 20193489040866, Lot Number: 0000073841; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000073746; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000077471; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000083091; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000083747; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000087523; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000090213; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000091658; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000095413; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000096109; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000099022; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000099532; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000115874; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000119624; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000125077; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000128639; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000131692; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000137761; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000141735; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000144496; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000151526; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000155679; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000157736; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 201934890

Quantity Affected: 1752096 kits

Reason for Recall

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Distribution

Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).

Type: Voluntary: Firm initiated

Recall Initiated: 2026-02-27

Company

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 232 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1718-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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