Recall Z-2508-2026
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) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.
Codes / lots: Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBQ975; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBF166; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23DBM780; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22KBM832; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22JBY524; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22GBR089; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBR153; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBC633; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22EBB478; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22BBX706; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot…
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-2508-2026
- Initiated
- May 4, 2026
- Posted by FDA
- June 17, 2026
- Product code
- OJH – Orthopedic Tray
- Quantity
- 3521 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-2493-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, 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 |