Class II Recall

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PRO

Summary

The FDA issued a Class II for Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOM by Medline Industries, LP. Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the hand.

Details

Source

Device Recall

External ID

Z-1087-2026

Action Date

2026-01-21

Status

Ongoing

Product Description

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924.

Lot/Code Info: REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870; REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25EBD110; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25DBG393; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25EBD631; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25DBM322; REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS), Lot Number 25DBT807; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25DMG099; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25CMJ006; REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS), Lot Number 25FDB347; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25EBK539; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25DBD145; REF DYNJ63392D: UDI/DI 10198459164507 (EA) 40198459164508 (CS), Lot Number 25BLA967; REF DYNJ68187B: UDI/DI 10198459382086 (EA) 40198459382087 (CS), Lot Number 25FMG440; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25EMH020; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25CMF917; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25FBK331; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25EBR783; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBP320; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBC981; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25DBA834; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25CBM884; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25FBK123; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25EBF929; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25CBT135; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25FMC215; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMF199; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMC621; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25FBO994; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25EBE439; REF DYNJ901847M: UDI/DI 10198459037863 (EA) 40198459037864 (CS), Lot Number 25BBM364; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25FBJ408; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25EBJ877; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBO236; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBC133; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMH506; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMD329; REF DYNJ905147B: UDI/DI 10193489569032 (EA) 40193489569033 (CS), Lot Number 25GDB060; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25DMK337; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25CMF465; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25EBG945; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25CBM218; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25EMD118; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25DMJ823; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMJ265; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC374; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC546; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25EBI860; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25DBR934; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25CBF096; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBJ655; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBE873; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25EBB258; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25DBR935; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25DMH137; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25CMJ730; REF DYNJ907405C: UDI/DI 10195327541392 (EA) 40195327541393 (CS), Lot Number 25CMF429; REF DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25FBG752; REF DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25DBS537; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25FDA930; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDB953; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDA576; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25DDA437; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25CDB060; REF DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577; REF DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577Z; REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25EBI127; REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBP413; REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBD522; REF DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25EBF813; REF DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25DBD407; REF DYNJ910924: UDI/DI 10198459203442 (EA) 40198459203443 (CS), Lot Number 25EBK656.

Quantity Affected: 4536 units

Reason for Recall

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-12-16

Company

Medline Industries, LP

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 161 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 II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

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-1087-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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