Recall Z-2493-2026
Medline Industries, LP · initiated May 4, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-2493-2026
- Initiated
- May 4, 2026
- Posted by FDA
- June 17, 2026
- Product code
- FDE – Laparoscopy Kit
- Quantity
- 10415 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2479-2026 Class II | MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2480-2026 Class II | MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2481-2026 Class II | MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2482-2026 Class II | MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2483-2026 Class II | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2484-2026 Class II | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2485-2026 Class II | MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2486-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2487-2026 Class II | MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2488-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2489-2026 Class II | MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2490-2026 Class II | MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2491-2026 Class II | MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2492-2026 Class II | MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2494-2026 Class II | MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2495-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2496-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2497-2026 Class II | MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2498-2026 Class II | MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2499-2026 Class II | MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2500-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2501-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2502-2026 Class II | MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2503-2026 Class II | MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2504-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2505-2026 Class II | MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2506-2026 Class II | MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2507-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |
| Z-2508-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097…During an internal review, Medline identified representative samples did not meet applicable performance… | 05/04/2026Open, Classified |