FDAFDA recall Z-2495-2026 · Jun 24, 2026

Medline Industries, LP: MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY recall

Recall found

Product

MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: Medline Kit Number/SKU DYKMBNDL117C: UDI/DI 10195327371104 (each), 40195327371105 (case), Lot Number 23DLA834; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23BMC463; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMA685; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMB905; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMG466; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMB983; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25JBD225; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25HBW236.
Quantity: 91 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
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-05-04

Source: openFDA enforcement record Z-2495-2026 · search recall number Z-2495-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.