Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) by Medline Industries, LP. Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali.

Details

Product Description

Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; 61) GYN PACK, Model Number: DYNJ86195A; 62) GYN LAPAROSCOPY, Model Number: DYNJ900262A; 63) D&C HYSTEROSCOPY, Model Number: DYNJ901133A; 64) GYN LAPAROSCOPY, Model Number: DYNJ901559J; 65) GYN ENDOSCOPY-LF, Model Number: DYNJ901812J; 66) GYN LITHOTOMY-LF, Model Number: DYNJ902711M; 67) GENERAL ROBOTIC, Model Number: DYNJ905066B; 68) TRINITY C-SEC W/LINEN CDS, Model Number: DYNJ905269G; 69) KIT GYN LAPAROSCOPY RFD, Model Number: DYNJ906322D; 70) GYN LAP LH, Model Number: DYNJ906452C; 71) GYN LAP LH, Model Number: DYNJ906452D; 72) GYN LAP LH, Model Number: DYNJ906452F; 73) FLOYD LITH GYN, Model Number: DYNJ906926B; 74) GYN LAPAROSCOPY-MRMC, Model Number: DYNJ907753F; 75) GYN LAPAROSCOPY-SFMC, Model Number: DYNJ907771C; 76) LAP/GYN ROBOTICS, Model Number: DYNJ908887B; 77) LAP/GYN ROBOTICS, Model Number: DYNJ908887C;

Lot/Code Info: 1) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240; 2) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781; 3) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBX440; 4) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBN644; 5) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23ABC549; 6) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22OBM422; 7) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22KBD152; 8) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22JBC547; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22HBV491; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22GBP114; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22FBV462; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22BBL450; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21IBM804; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21HBN807; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21GBI171; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21EBA117; 18) CDS984543D, UDI-DI: 10195327072322(each), 40195327072323(case), Lot Number: 22CBC587; 19) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22OBL925; 20) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22KMD619; 21) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22JMA223; 22) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMG671; 23) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMB259; 24) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22GBD616; 25) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24BMH483; 26) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23LMA864; 27) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23JMC376; 28) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23IMA629; 29) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMH282; 30) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMF425; 31) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23FMI171; 32) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23EMI460; 33) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23DMA508; 34) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23CMC582; 35) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23BMD680; 36) CDS984543I, UDI-DI: 10195327637071(each), 40195327637072(case), Lot Number: 24CMH050; 37) CDS984860F, UDI-DI: 10193489261974(each), 40193489261975(case), Lot Number: 21ADB205; 38) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21DBV243; 39) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH547; 40) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH282; 41) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25LBN225; 42) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25HBS386; 43) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25FBS108; 44) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25DBN805; 45) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21JBD206; 46) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21GBP406; 47) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21EBA097; 48) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21BBG514; 49) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21ABI962; 50) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABW347; 51) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABO060; 52) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABM086; 53) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24DBA349; 54) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24CBF889; 55) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24JBB328; 56) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24IBV184; 57) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24GBK948; 58) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24FBC411; 59) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24DBS388; 60) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22HBL832; 61) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22FBI695; 62) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22CBX517; 63) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22BBR618; 64) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBY301; 65) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBP646; 66) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBX803; 67) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBC127; 68) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21HBK337; 69) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21FBP762; 70) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21EBG218; 71) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBP181; 72) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBA024; 73) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABL615; 74) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABJ213; 75) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25HBB957; 76) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25GBX843; 77) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25FBR662; 78) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBI207; 79) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBF533; 80) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24JBD270; 81) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24DBV608; 82) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24CBJ465; 83) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24ABX678; 84) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23LBE369; 85) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23KBA328; 86) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 22JBC546; 87) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22HBP253; 88) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22CBX518; 89) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL299; 90) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL283; 91) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21KBQ606; 92) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21JBJ225; 93) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21IBL095; 94) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBU222; 95) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBP369; 96) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21EBK837; 97) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21BBG518; 98) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21ABI984; 99) DYKMBNDL168A, UDI-DI: 10195327240806(each), 40195327240807(case), Lot Number: 23FBJ346; 100) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBQ333; 101) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBG179; 102) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25HBC798; 103) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25FBJ143; 104) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25BBF014; 105) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25ABS671; 106) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24HBK278; 107) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBV008; 108) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBJ568; 109) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22HBB985; 110) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22GBZ017; 111) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21LBJ751; 112) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21IBO770; 113) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21HBK341; 114) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21FBP714; 115) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21BBG520; 116) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21ABJ086; 117) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22HLA664; 118) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELB163; 119) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELA227; 120) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22DLB036; 121) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22CLA119; 122) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22BLA918; 123) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA331; 124) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA125; 125) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA284; 126) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA163; 127) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21JLA896; 128) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21HLA598; 129) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA658; 130) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA352; 131) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA256; 132) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21DLA017; 133) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21BLA496; 134) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ABJ861; 135) DYKMBNDL92A, UDI-DI: 10195327241209(each), 40195327241200(case), Lot Number: 22KLA731; 136) DYKMBNDL92A, UDI-DI: 10195327241209(each), 40195327241200(case), Lot Number: 22JLA665; 137) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25ILA134; 138) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25HLA275; 139) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25GLA701; 140) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25ELA660; 141) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25DLB036; 142) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25BLA797; 143) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLB092; 144) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLA506; 145) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLA194; 146) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24JLB140; 147) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24JLA881; 148) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24HLB219; 149) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24HLB142; 150) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 22HBH516; 151) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 22FBK394; 152) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21IBV704; 153) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21HBO271; 154) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21GBB013; 155) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21CBS045; 156) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21CBB287; 157) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21ABM148; 158) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 20LBY985; 159) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23BBI491; 160) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABO813; 161) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABK219; 162) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABJ591; 163) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 22LBS837; 164) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25CBR621; 165) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25BBA805; 166) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25ABN371; 167) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25ABH279; 168) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24LBN994; 169) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24KBA746; 170) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24IBE086; 171) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24EBV430; 172) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24DBR903; 173) DYKMBNDL94D, UDI-DI: 10198459350641(each), 40198459350642(case), Lot Number: 25EBN175; 174) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24HBX130; 175) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24HBA113; 176) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24EBT021; 177) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24EBM495; 178) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24DBL074; 179) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24CBM999; 180) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24BBH633; 181) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24ABI719; 182) DYNJ0347372F, UDI-DI: 10195327213176(each), 40195327213177(case), Lot Number: 22GBR392; 183) DYNJ0347372G, UDI-DI: 10195327266028(each), 40195327266029(case), Lot Number: 23DBP818; 184) DYNJ0347372G, UDI-DI: 10195327266028(each), 40195327266029(case), Lot Number: 22KBU586; 185) DYNJ0347372I, UDI-DI: 10195327418335(each), 40195327418336(case), Lot Number: 23IBK088; 186) DYNJ0347372I, UDI-DI: 10195327418335(each), 40195327418336(case), Lot Number: 23GBO695; 187) DYNJ28252G, UDI-DI: 10198459088124(each), 40198459088125(case), Lot Number: 25CBC137; 188) DYNJ28252G, UDI-DI: 10198459088124(each), 40198459088125(case), Lot Number: 25BBP572; 189) DYNJ30005G, UDI-DI: 10193489601794(each), 40193489601795(case), Lot Number: 21DMA051; 190) DYNJ32706B, UDI-DI: 10195327364304(each), 40195327364305(case), Lot Number: 23EMB628; 191) DYNJ38844N, UDI-DI: 10195327243166(each), 40195327243167(case), Lot Number: 23HBI619; 192) DYNJ38844N, UDI-DI: 10195327243166(each), 40195327243167(case), Lot Number: 23DBI585; 193) DYNJ47550C, UDI-DI: 10195327209964(each), 40195327209965(case), Lot Number: 23DBD093; 194) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 25KBF492; 195) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 24FBG329; 196) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 24CBQ847; 197) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23HBO785; 198) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23FBU806; 199) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23FBH830; 200) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 23CMB495; 201) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22KMH193; 202) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22HMC351; 203) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22HMA973; 204) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22EMA211; 205) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22BMH522; 206) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21KMG274; 207) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21JMH124; 208) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21JMF391; 209) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21GMD682; 210) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21AMA809; 211) DYNJ49705K, UDI-DI: 10195327020347(each), 40195327020348(case), Lot Number: 22IMI306; 212) DYNJ50348F, UDI-DI: 10195327406349(each), 40195327406340(case), Lot Number: 23IMD230; 213) DYNJ50439F, UDI-DI: 10193489704921(each), 40193489704922(case), Lot Number: 22EBC737; 214) DYNJ51795F, UDI-DI: 10193489475937(each), 40193489475938(case), Lot Number: 21ADA184; 215) DYNJ51795F, UDI-DI: 10193489475937(each), 40193489475938(case), Lot Number: 20LDC148; 216) DYNJ52569B, UDI-DI: 10193489685190(each), 40193489685191(case), Lot Number: 23EBS784; 217) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 23BBA462; 218) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22LBD784; 219) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22HBV228; 220) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22GBJ776; 221) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22ABC476; 222) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21JBR818; 223) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21IBG462; 224) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21CBU815; 225) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21GME150; 226) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21FMB889; 227) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21EMB589; 228) DYNJ58321A, UDI-DI: 10193489489316(each), 40193489489317(case), Lot Number: 22ABG197; 229) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 22AME373; 230) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21JMF224; 231) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21HMD002; 232) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21EMF383; 233) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21DMB839; 234) DYNJ63079C, UDI-DI: 10195327102180(each), 40195327102181(case), Lot Number: 23GMB716; 235) DYNJ63079C, UDI-DI: 10195327102180(each), 40195327102181(case), Lot Number: 23EMI624; 236) DYNJ63079D, UDI-DI: 10195327505677(each), 40195327505678(case), Lot Number: 24BME368; 237) DYNJ63079D, UDI-DI: 10195327505677(each), 40195327505678(case), Lot Number: 23JMB435; 238) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25JMK630; 239) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25JMH582; 240) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25AMH256; 241) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24JMD681; 242) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24HMH481; 243) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24HMC603; 244) DYNJ64266, UDI-DI: 10193489795516(each), 40193489795517(case), Lot Number: 21ADA447; 245) DYNJ66298D, UDI-DI: 10195327095895(each), 40195327095896(case), Lot Number: 23IBW233; 246) DYNJ67269, UDI-DI: 10193489394696(each), 40193489394697(case), Lot Number: 22KBG504; 247) DYNJ68710, UDI-DI: 10193489842906(each), 40193489842907(case), Lot Number: 22ABM641; 248) DYNJ69419A, UDI-DI: 10195327223588(each), 40195327223589(case), Lot Number: 23DBK434; 249) DYNJ69419A, UDI-DI: 10195327223588(each), 40195327223589(case), Lot Number: 23ABS144; 250) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24KMH362; 251) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24KME386; 252) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24GMG805; 253) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24GMC135; 254) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24EMD677; 255) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24EMC427; 256) DYNJ81492A, UDI-DI: 10195327348830(each), 40195327348831(case), Lot Number: 23BBT116; 257) DYNJ81761A, UDI-DI: 10195327574468(each), 40195327574469(case), Lot Number: 24FMF687; 258) DYNJ83475A, UDI-DI: 10195327460938(each), 40195327460939(case), Lot Number: 23HBY488; 259) DYNJ84783, UDI-DI: 10195327417949(each), 40195327417940(case), Lot Number: 23IBU517; 260) DYNJ86195A, UDI-DI: 10195327682286(each), 40195327682287(case), Lot Number: 24EBD237; 261) DYNJ900262A, UDI-DI: 10195327477820(each), 40195327477821(case), Lot Number: 23KBU736; 262) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 22JBR884; 263) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21KBP568; 264) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21KBF079; 265) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21JBV891; 266) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21JBM245; 267) DYNJ901559J, UDI-DI: 10193489235890(each), 40193489235891(case), Lot Number: 21EBR740; 268) DYNJ901559J, UDI-DI: 10193489235890(each), 40193489235891(case), Lot Number: 21CBH289; 269) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21FDB236; 270) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21BDA744; 271) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21ADB190; 272) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25GBR954; 273) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25EBK653; 274) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25DBB182; 275) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25ABS755; 276) DYNJ905066B, UDI-DI: 10195327098674(each), 40195327098675(case), Lot Number: 23BMF722; 277) DYNJ905066B, UDI-DI: 10195327098674(each), 40195327098675(case), Lot Number: 23BMB931; 278) DYNJ905269G, UDI-DI: 10193489337112(each), 40193489337113(case), Lot Number: 21BBD394; 279) DYNJ905269G, UDI-DI: 10193489337112(each), 40193489337113(case), Lot Number: 21ABH751; 280) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23FBE986; 281) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23EBQ671; 282) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23DBT141; 283) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 22GBL545; 284) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23FBP128; 285) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23DBM357; 286) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23BBB047; 287) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23BBA689; 288) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25IBI139; 289) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25HBO792; 290) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25GBB683; 291) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25EBA889; 292) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25BBO090; 293) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25ABT788; 294) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24LBN196; 295) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24KBJ970; 296) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24IBN246; 297) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24HBM625; 298) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24FBJ836; 299) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24DBT181; 300) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24CBS248; 301) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24BBN302; 302) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24ABD306; 303) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23LBJ184; 304) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23JBT789; 305) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23IBO509; 306) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23HBO123; 307) DYNJ906452F, UDI-DI: 10198459575303(each), 40198459575304(case), Lot Number: 25KBG657; 308) DYNJ906926B, UDI-DI: 10193489921366(each), 40193489921367(case), Lot Number: 23EBN137; 309) DYNJ907753F, UDI-DI: 10195327194482(each), 40195327194483(case), Lot Number: 22LBN185; 310) DYNJ907771C, UDI-DI: 10195327120399(each), 40195327120390(case), Lot Number: 22LBP170; 311) DYNJ908887B, UDI-DI: 10195327620158(each), 40195327620159(case), Lot Number: 24DBD796; 312) DYNJ908887B, UDI-DI: 10195327620158(each), 40195327620159(case), Lot Number: 24CBP744; 313) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24LBP187; 314) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24JBP902; 315) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24HBI648; 316) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24GBK492; 317) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24EBM187; 318) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23KME175; 319) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23JMB528; 320) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23HMI269; 321) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24HMA202; 322) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24DMI073; 323) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24CMI706; 324) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24BMA251; 325) DYNJ910536, UDI-DI: 10198459029554(each), 40198459029555(case), Lot Number: 24GBA620; 326) DYNJ910536A, UDI-DI: 10198459054358(each), 40198459054359(case), Lot Number: 24IBE833; 327) DYNJ910589, UDI-DI: 10198459040894(each), 40198459040895(case), Lot Number: 24HBF839; 328) DYNJ910594, UDI-DI: 10198459041327(each), 40198459041328(case), Lot Number: 24HBF837; 329) DYNJ911567, UDI-DI: 10198459409004(each), 40198459409005(case), Lot Number: 25HBB593; 330) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21DMF113; 331) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21CKA812; 332) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21CKA647; 333) DYNJ9701096I, UDI-DI: 10193489939651(each), 40193489939652(case), Lot Number: 22AMC654; 334) DYNJT3381, UDI-DI: 10198459325205(each), 40198459325206(case), Lot Number: 25EBK724

Quantity Affected: 12418 units

Reason for Recall

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-01-07

Company