medical MODERATE Updated 2026-06-24

Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLO

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Recalled Product

MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Kit Number/SKU DYNJ909989B; 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53214; 5) DIAGNOSTIC LAPAROSCOPY, Medline Kit Number/SKU DYNJ903390K; 6) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700C; 7) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700D; 8) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700F; 9) GENERAL-CVOR MINOR, Medline Kit Number/SKU DYNJ64324A; 10) GYN LAP, Medline Kit Number/SKU DYNJT7061; 11) GYN LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53631F; 12) GYN MINOR PACK, Medline Kit Number/SKU DYNJ85910; 13) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117A; 14) LAP, Medline Kit Number/SKU DYNJ904585B; 15) LAP, Medline Kit Number/SKU DYNJ904585C; 16) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255R; 17) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255S; 18) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255T; 19) LAPAROSCOPY, Medline Kit Number/SKU DYNJ89908; 20) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517; 21) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517A; 22) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958I; 23) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958J; 24) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992C; 25) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992D; 26) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992F; 27) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992G; 28) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992I; 29) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ67160; 30) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ84211; 31) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJHS0235C; 32) LAPAROSCOPY PACK VICTORY, Medline Kit Number/SKU DYNJ81148; 33) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ14073B; 34) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404A; 35) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404B; 36) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404C; 37) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404D; 38) LAPAROSCOPY/GYN PACK, Medline Kit Number/SKU DYNJ0384702U; 39) PACK LAPAROSCOPY, Medline Kit Number/SKU DYNJ0553254O; 40) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046A; 41) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046B; 42) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046C; 43) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046D; 44) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046F; 45) PROLAPSE PACK, Medline Kit Number/SKU DYNJ85390; 46) RICH CYSTO, Medline Kit Number/SKU DYNJ902183I; 47) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263B; 48) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263C; 49) SMJ LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ25763J; 50) WCH GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700G.

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Hazard / Issue

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 26BBD116; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 26ABL500; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25FBH410; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25EBQ051; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25DBS969; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24LBQ812; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24LBF658; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24JBM406; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 23GBM492; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22IBV269; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22HBV981; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22HBF916; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25GBW197; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25GBD634; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25FBB533; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25EBC752; DYNJ53214: UDI/DI 10889942388301 (each), 40889942388302 (case), Lot Number 21HMG546; DYNJ53214: UDI/DI 10889942388301 (each), 40889942388302 (case), Lot Number 21HMC179; DYNJ903390K: UDI/DI 10198459522826 (each), 40198459522827 (case), Lot Number 26ABQ562; DYNJ903390K: UDI/DI 10198459522826 (each), 40198459522827 (case), Lot Number 25JBB643; DYNJ902700C: UDI/DI 10889942253876 (each), 40889942253877 (case), Lot Number 21EBL762; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23GBH673; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23GBH781; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23DBI173; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23DBJ926; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23BBG583; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23ABT448; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 21IBA024; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 21IBA023; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 24BBP837; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 24BBP021; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 23LBL539; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25FBC637; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25EBF271; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25CBK107; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 24GBH161; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 24BBQ307; DYNJT7061: UDI/DI 10198459594816 (each), 40198459594817 (case), Lot Number 25LBJ399; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 22CBU291; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 22BBB868; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21LBW055; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21IBQ254; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21EBR254; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21DBO515; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21DBE409; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21BBM589; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24FMB929A; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24FMB929; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24DME859; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24BMK071; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24BMD100; DYKMBNDL117A: UDI/DI 10193489882773 (each), 40193489882774 (case), Lot Number 22ELA421; DYKMBNDL117A: UDI/DI 10193489882773 (each), 40193489882774 (case), Lot Number 22ALA614; DYKMBNDL117A: UDI/DI 10193489882773 (each), 40193489882774 (case), Lot Number 22BLB033; DYNJ904585B: UDI/DI 10889942793082 (each), 40889942793083 (case), Lot Number 21KBD965; DYNJ904585B: UDI/DI 10889942793082 (each), 40889942793083 (case), Lot Number 21JBH232; DYNJ904585B: UDI/DI 10889942793082 (each), 40889942793083 (case), Lot Number 21BBA929; DYNJ904585C: UDI/DI 10195327109660 (each), 40195327109661 (case), Lot Number 23IBN073; DYNJ904585C: UDI/DI 10195327109660 (each), 40195327109661 (case), Lot Number 23EBM768; DYNJ904585C: UDI/DI 10195327109660 (each), 40195327109661 (case), Lot Number 23CBT300; DYNJ904585C: UDI/DI 10195327109660 (each), 40195327109661 (case), Lot Number 23CBE808; DYNJ904585C: UDI/DI 10195327109660 (each), 40195327109661 (case), Lot Number 22FBA957; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 24GMC198; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 24FMC309; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 24EMF666; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 24DMA901; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 24CMB493; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 24BMC401; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 23KMI607; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 23JMF027; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 23HMB579; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 23HMA393; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 23GMD908; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 23DMH025; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 22KME865; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 22KME866; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 22JMC338; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 22GMD550; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 22FMA579; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 22EMF312; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21KMA530; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21JMB058; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21IMG736; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21IMD097; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21HMD022; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21GME490; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21GMB296; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21FME851; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 21DKA288; CDS983255R: UDI/DI 10193489689716 (each), 40193489689717 (case), Lot Number 22DMB055; CDS983255S: UDI/DI 10198459060014 (each), 40198459060015 (case), Lot Number 25FMG657; CDS983255S: UDI/DI 10198459060014 (each), 40198459060015 (case), Lot Number 25CMI100; CDS983255S: UDI/DI 10198459060014 (each), 40198459060015 (case), Lot Number 25AMG951; CDS983255S: UDI/DI 10198459060014 (each), 40198459060015 (case), Lot Number 24LMA249; CDS983255S: UDI/DI 10198459060014 (each), 40198459060015 (case), Lot Number 24HMF023; CDS983255T: UDI/DI 10198459389122 (each), 40198459389123 (case), Lot Number 26DMA902; CDS983255T: UDI/DI 10198459389122 (each), 40198459389123 (case), Lot Number 26AMD388; CDS983255T: UDI/DI 10198459389122 (each), 40198459389123 (case), Lot Number 25HMH537; DYNJ89908: UDI/DI 10198459297328 (each), 40198459297329 (case), Lot Number 25DBC466; DYNJ910517: UDI/DI 10198459021442 (each), 40198459021443 (case), Lot Number 24KBM785; DYNJ910517: UDI/DI 10198459021442 (each), 40198459021443 (case), Lot Number 24IBE100; DYNJ910517: UDI/DI 10198459021442 (each), 40198459021443 (case), Lot Number 24FBH143; DYNJ910517A: UDI/DI 10198459203930 (each), 40198459203931 (case), Lot Number 26BBH854; DYNJ910517A: UDI/DI 10198459203930 (each), 40198459203931 (case), Lot Number 25KBM864; DYNJ910517A: UDI/DI 10198459203930 (each), 40198459203931 (case), Lot Number 25IBC599; DYNJ910517A: UDI/DI 10198459203930 (each), 40198459203931 (case), Lot Number 25GBV641; DYNJ910517A: UDI/DI 10198459203930 (each), 40198459203931 (case), Lot Number 25EBB704; DYNJ910517A: UDI/DI 10198459203930 (each), 40198459203931 (case), Lot Number 25BBK272; DYNJ910517A: UDI/DI 10198459203930 (each), 40198459203931 (case), Lot Number 25ABS355; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 24IBS262; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 24IBG495; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 24EBD328; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 24CBH840; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 23GBS762; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 23FBH413; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 23EBB909; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 23CBK544; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 22JBF669; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 22FBV264; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 22BBR479; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 21KBJ160; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 21GBE109; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 21GBE126; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 21FBH730; DYNJ06958I: UDI/DI 10888277043305 (each), 40888277043306 (case), Lot Number 21EBC527; DYNJ06958J: UDI/DI 10198459208133 (each), 40198459208134 (case), Lot Number 25CBG730; DYNJ06958J: UDI/DI 10198459208133 (each), 40198459208134 (case), Lot Number 25ABW220; DYNJ53992C: UDI/DI 10193489764833 (each), 40193489764834 (case), Lot Number 21DBR336; DYNJ53992C: UDI/DI 10193489764833 (each), 40193489764834 (case), Lot Number 21BBM609; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 22HMB182; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 22GME899; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 22FME625; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 22DMI179; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 22OBL246; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 22CBJ195; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 21LBM559; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 21LBM560; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 21VBB076; DYNJ53992D: UDI/DI 10193489951059 (each), 40193489951050 (case), Lot Number 21GBJ693; DYNJ53992F: UDI/DI 10195327282899 (each), 40195327282890 (case), Lot Number 23IMG590; DYNJ53992F: UDI/DI 10195327282899 (each), 40195327282890 (case), Lot Number 23HMF302; DYNJ53992F: UDI/DI 10195327282899 (each), 40195327282890 (case), Lot Number 23GME635; DYNJ53992F: UDI/DI 10195327282899 (each), 40195327282890 (case), Lot Number 23DMI266; DYNJ53992F: UDI/DI 10195327282899 (each), 40195327282890 (case), Lot Number 23DMA357; DYNJ53992F: UDI/DI 10195327282899 (each), 40195327282890 (case), Lot Number 23CMB871; DYNJ53992F: UDI/DI 10195327282899 (each), 40195327282890 (case), Lot Number 23AMB100; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 25HMF365; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 25EMF432; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 25DMG516; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 25CMH158; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 25AMJ024; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 24JMI936; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 24IMH237; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 24HMC573; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 24GMK025; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 24EMF773; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 24EMB454; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 24AMB736; DYNJ53992G: UDI/DI 10195327532710 (each), 40195327532711 (case), Lot Number 23LMB368; DYNJ53992I: UDI/DI 10198459509742 (each), 40198459509743 (case), Lot Number 26DMB674; DYNJ53992I: UDI/DI 10198459509742 (each), 40198459509743 (case), Lot Number 26BMH529; DYNJ53992I: UDI/DI 10198459509742 (each), 40198459509743 (case), Lot Number 26AMG137; DYNJ53992I: UDI/DI 10198459509742 (each), 40198459509743 (case), Lot Number 25KME427; DYNJ53992I: UDI/DI 10198459509742 (each), 40198459509743 (case), Lot Number 25JMF523; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 23JBD169; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 23HBZ438; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 23HBW565; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 23HBB442; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 23FBR674; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 23EBK635; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22JBX164; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22JBW335; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22JBX720; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22HBQ011; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22HBD617; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22HBA717; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22DBN952; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22BBY461; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 22ABX190; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 21KBO144; DYNJ67160: UDI/DI 10193489395907 (each), 40193489395908 (case), Lot Number 21IBQ873; DYNJ84211: UDI/DI 10195327342876 (each), 40195327342877 (case), Lot Number 23HMB192; DYNJ84211: UDI/DI 10195327342876 (each), 40195327342877 (case), Lot Number 23FMD350; DYNJ84211: UDI/DI 10195327342876 (each), 40195327342877 (case), Lot Number 23DMF493; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 22EMB906; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 22CMH997; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 22AMA029; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21KMH498; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21KMF110; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21JMA297A; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21JMA297; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21HME789; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21GMA762; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21CMC927; DYNJHS0235C: UDI/DI 10889942635245 (each), 40889942635246 (case), Lot Number 21AME355; DYNJ81148: UDI/DI 10195327087609 (each), 40195327087600 (case), Lot Number 22IBS543; DYNJ81148: UDI/DI 10195327087609 (each), 40195327087600 (case), Lot Number 22IBR964; DYNJ81148: UDI/DI 10195327087609 (each), 40195327087600 (case), Lot Number 22FBV834; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 26CBL117; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 25HBH402; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 25EBN104; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 25BBE826; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 24IBQ562; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 24IBB836; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 24HBA872; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 24EBP967; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 24BBV951; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 23KBO595; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 23IBR123; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 23EBI396; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 23DBI583; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 22LBF875; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 22KBJ661; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 22JBG061; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 22IBA049; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 22CBT304; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 21LBL036; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 21KBP348; DYNJ14073B: UDI/DI 10884389637166 (each), 40884389637167 (case), Lot Number 21VBC669; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 24CBK293; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 24CBG602; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 24BBI866; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 24ABT739; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 23KBI484; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 22KBW296; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 22GBK753; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 22GBE833; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 22FBX879; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 22EBU471; DYNJ61404A: UDI/DI 10193489619591 (each), 40193489619592 (case), Lot Number 21KBG020; DYNJ61404B: UDI/DI 10198459013973 (each), 40198459013974 (case), Lot Number 25FBA725; DYNJ61404B: UDI/DI 10198459013973 (each), 40198459013974 (case), Lot Number 25ABR108; DYNJ61404B: UDI/DI 10198459013973 (each), 40198459013974 (case), Lot Number 24IBG915; DYNJ61404C: UDI/DI 10198459515552 (each), 40198459515553 (case), Lot Number 25IBL608; DYNJ61404D: UDI/DI 10198459538711 (each), 40198459538712 (case), Lot Number 26ABQ031; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 26AMH031; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 25JMJ998; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 25HMF578; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 25GMC119; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 25FMA130; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 25DMD994; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 25CMA922; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 24LMH259; DYNJ0384702U: UDI/DI 10198459106996 (each), 40198459106997 (case), Lot Number 24KMB187; DYNJ0553254O: UDI/DI 10193489488388 (each), 40193489488389 (case), Lot Number 21AME239; DYNJ0553254O: UDI/DI 10193489488388 (each), 40193489488389 (case), Lot Number 21AMA546; DYNJ908046A: UDI/DI 10195327144685 (each), 40195327144686 (case), Lot Number 22FDB153; DYNJ908046B: UDI/DI 10195327178857 (each), 40195327178858 (case), Lot Number 22KDA230; DYNJ908046B: UDI/DI 10195327178857 (each), 40195327178858 (case), Lot Number 22JDA989; DYNJ908046B: UDI/DI 10195327178857 (each), 40195327178858 (case), Lot Number 22IDA125; DYNJ908046C: UDI/DI 10195327313494 (each), 40195327313495 (case), Lot Number 23EDC170; DYNJ908046C: UDI/DI 10195327313494 (each), 40195327313495 (case), Lot Number 23DDB583; DYNJ908046C: UDI/DI 10195327313494 (each), 40195327313495 (case), Lot Number 23ADB627; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 25BMI715; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24LDB817; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24LDA755; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24KDB596; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24JDB136; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24IDB257; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24GDB746; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24FDC002; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24FDB556; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24DDB131; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 24BDA548; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 23LDC089; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 23KDA551; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 23IDB328; DYNJ908046D: UDI/DI 10195327420512 (each), 40195327420513 (case), Lot Number 23HDA536; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25LMA900; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25KMI884; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25JMA778; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25HMC460; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25FMB976; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25EME560; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25DMJ830; DYNJ908046F: UDI/DI 10198459312328 (each), 40198459312329 (case), Lot Number 25DMC199; DYNJ85390: UDI/DI 10195327496562 (each), 40195327496563 (case), Lot Number 23LBE880; DYNJ85390: UDI/DI 10195327496562 (each), 40195327496563 (case), Lot Number 23KBM872; DYNJ902183I: UDI/DI 10195327390235 (each), 40195327390236 (case), Lot Number 24CBF429; DYNJ902183I: UDI/DI 10195327390235 (each), 40195327390236 (case), Lot Number 23LBG119; DYNJ902183I: UDI/DI 10195327390235 (each), 40195327390236 (case), Lot Number 23JBR734; DYNJ902183I: UDI/DI 10195327390235 (each), 40195327390236 (case), Lot Number 23JBN256; DYNJ902183I: UDI/DI 10195327390235 (each), 40195327390236 (case), Lot Number 23HBF092; DYNJ902183I: UDI/DI 10195327390235 (each), 40195327390236 (case), Lot Number 23GBI795; DYNJ66263B: UDI/DI 10195327352950 (each), 40195327352951 (case), Lot Number 23JBP151; DYNJ66263B: UDI/DI 10195327352950 (each), 40195327352951 (case), Lot Number 23HBR773; DYNJ66263B: UDI/DI 10195327352950 (each), 40195327352951 (case), Lot Number 23EBP201; DYNJ66263B: UDI/DI 10195327352950 (each), 40195327352951 (case), Lot Number 23BBS137; DYNJ66263C: UDI/DI 10195327635053 (each), 40195327635054 (case), Lot Number 24FMB873; DYNJ66263C: UDI/DI 10195327635053 (each), 40195327635054 (case), Lot Number 24EBB572; DYNJ25763J: UDI/DI 10889942360932 (each), 40889942360933 (case), Lot Number 21KMF632; DYNJ25763J: UDI/DI 10889942360932 (each), 40889942360933 (case), Lot Number 21KME064; DYNJ25763J: UDI/DI 10889942360932 (each), 40889942360933 (case), Lot Number 21IMB840; DYNJ25763J: UDI/DI 10889942360932 (each), 40889942360933 (case), Lot Number 21EMB720; DYNJ25763J: UDI/DI 10889942360932 (each), 40889942360933 (case), Lot Number 21EMB285; DYNJ25763J: UDI/DI 10889942360932 (each), 40889942360933 (case), Lot Number 21DMA464; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 25JBX250; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 25IBU398; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 25HBG229; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 25FBK873; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 25FBG070; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 24LBR443; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 24KBO140; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 24JBO727; DYNJ902700G: UDI/DI 10195327680312 (each), 40195327680313 (case), Lot Number 24HBL056.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall