Recall archive / FDA device enforcement
MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/... — FDA record Z-2493-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 10415 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2493-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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: ... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 24, 2026
- Recall initiation date
- May 4, 2026
- Center classification date
- Jun 17, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.