Medline Industries, Lp: Cardiovascular Procedure Kit
Recall Summary Medline Industries is recalling 21 cardiovascular surgical kits distributed nationwide because cannula components in the kits don't meet safety standards and may leak or break during use. The affected kits are used in heart and vascular procedures and were distributed to hospitals and medical facilities across all U.S. states. Healthcare providers who received these kits should check their product numbers against the recall list.
- Recalling firm
- Medline Industries, LP
- Product
- Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product number/SKU CDS840379O; 5) MINOR VASCULAR PACK-LF, Medline product number/SKU DYNJ0349727D; 6) SJHC VASCULAR PK-LF, Medline product number/SKU DYNJ19906L; 7) CABG PACK-LF, Medline product number/SKU DYNJ0824648K; 8) PERIPHERAL VASC MNR-LF, Medline product number/SKU DYNJ22721N; 9) HEART A PACK, Medline product number/SKU...
- 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 II
- 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/444c2f3c-2150-4ed3-af98-7ad7b79a6638