Recall Z-2007-2026 ยท LRO General Surgery Tray
Medical Action Industries, Inc. 306
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
| Date | May 6, 2026 (initiated Mar 17, 2026) |
| Status | Open, Classified |
| Reason | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold" |
| Root cause | Unknown/Undetermined by firm |
| Action | On April 22, 2026, Medial Action Industries, Inc. (subsidiary of Owens & Minor) issued a "Urgent: Medical Device Recall Notification Update" via E-Mail to affected consignees. The updated notification provided clarity and and additional information for the recall strategy. Initial notification was issued on March 17, 2026. Medical Action Industries asked consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product. Convenience kits can still be used once properly labeled. 2. Add warning labels to affected Medical Action kits to ensure all users a |
| Quantity | 2030 kits |
| Distribution | US distribution to state of: AZ OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.