Medline Industries, Lp: General Surgery Tray
Recall Summary Medline Industries is recalling 29 surgical convenience kits used in heart, vascular, and transplant procedures because they contain cannula components that don't meet required dimensional standards and may leak or break during surgery. The kits were distributed nationwide across all U.S. states and the District of Columbia. Healthcare facilities that received these products should identify them by the kit names and product numbers listed above.
- Recalling firm
- Medline Industries, LP
- Product
- Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product number/SKU DYNJ53741N; 5) OPEN HEART PACK 1&2, Medline Product number/SKU DYNJ80701A; 6) VEIN PACK, Medline Product number/SKU DYNJ67308C; 7) OPEN HEART PACK, Medline Product number/SKU DYNJ89451B; 8) VASCULAR TRAY-LF, Medline Product number/SKU DYNJ42166A; 9) ENDOSCOPIC VEIN HARVEST PK, 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/32b6a8ac-64b0-4ba3-97ed-bbeeaa6946c7