Medline Industries, Lp: Kit, Surgical Instrument, Disposable
Recall Summary Medline Industries is recalling three lots of CV Basin Pack surgical convenience kits (product numbers DYNJ0538615K, DYNJ0538615J, and DYNJ0538615L) distributed nationwide because the cannula components don't meet required safety standards and may leak or break during use. The recall affects medical facilities across all U.S. states and territories that received these kits.
- Recalling firm
- Medline Industries, LP
- Product
- Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
- Reason
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e6ef31f4-46a2-489e-b36e-1c8eb4d94ffa