Recall Z-2501-2026
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) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.
Codes / lots: Medline Kit Number/SKU DYNJ47625B, UDI/DI 10889942182589 (each), 40889942182580 (case), Lot Number 21LBI584; Medline Kit Number/SKU DYNJ912219, UDI/DI 10198459676048 (each), 40198459676049 (case), Lot Number 26BBQ085; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 23BBK437; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22LBP927; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22KBA970; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22JBH943; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22HBR879; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 25ABD038; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24IBP599; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24HBT938; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (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-2501-2026
- Initiated
- May 4, 2026
- Posted by FDA
- June 17, 2026
- Product code
- MLS – Labor And Delivery Kit
- Quantity
- 24388 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-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 |