Medline Industries, Lp: Ct Biopsy Tray
Medline is recalling its Bilateral Micro Vasectomy Reversal Kit (SKU DYNJ68302) due to quality issues found during an internal review, including surface irregularities on catheters, premature detachment of catheter connectors, and catheters that don't meet diameter specifications. The product was distributed nationwide in the US and in several other countries including Canada, the Netherlands, and others. This is a Class II recall, meaning the product could cause serious health consequences or temporary adverse health effects.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8cf11111-d267-4351-823e-0e2f3d4387c3