Recall Z-2496-2026
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) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.
Codes / lots: Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22HMA818; Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22GMG188; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23FMB021; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23CMB395; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23BMF105; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 25BMG115; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG981; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG043; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KME988; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24JMC883; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110…
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-2496-2026
- Initiated
- May 4, 2026
- Posted by FDA
- June 17, 2026
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Quantity
- 1432 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-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 |