FDAFDA · Food and drugs·Recall number Z-2502-2026
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
Published June 24, 2026 · Recall initiated: May 4, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Lot
- UDI/DI 10195327548261 (each), 40195327548262 (case). Lot Numbers: 25LBI062, 25HBR967, 24JBK618, 24BBQ860.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.