FDAFDA · Food and drugs·Recall number Z-2495-2026
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.
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
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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