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)
FDA Recall Z-2506-2026 · Posted 2026-06-17
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Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOKV
Date Initiated2026-05-04
Product Quantity32438 units
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.
Firm Action
Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers.
For questions, contact the Recall Department at 866-359-1704 or [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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