Medline Industries, Lp: Labor And Delivery Kit

Recall Summary Medline is recalling 15 labor and delivery medical kits used in hospitals and medical facilities because sample testing found defects in catheters included in the kits, including surface irregularities, connectors that detach prematurely, and incorrect outer diameters. The kits were distributed nationwide in the US and to several other countries. This is a Class II recall, meaning the defects could cause temporary health problems but are not life-threatening.

Recalling firm: Medline Industries, LP
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...
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
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-05-04
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Recall details on Nibble Recalls: https://trynibble.app/recalls/f321787b-447b-417c-a13f-eb9ad009674b