FDA Medical devices recall ·
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY… recall
- Recall number
- Z-2506-2026
- Date
- (initiated May 4, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32438 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25HBR321; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25GBD202; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25FBK813; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25EBG207; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23FBK499; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23EBV071; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22KBK089; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22IBV707; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22HBC310; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26DMG168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26CMD637; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25KMC849; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25JMA672; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (ca
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
States: California Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2506-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.