Recall Z-1482-2026 ยท LCJ Tissue Expander And Accessories
B Braun Medical Inc
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
| Date | Mar 2, 2026 (initiated Feb 2, 2026) |
| Status | Open, Classified |
| Reason | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. |
| Root cause | Process control |
| Action | On February 2, 2026 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken: 1. Review the notice in its entirety and ensure that all users in your organization are aware and informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the hospital/healthcare facility level. 2. Examine inventory for affected product, cease use and quarantine product subject to recall. Do not destroy any affected product. 5. Once we receive your Acknowl |
| Quantity | 21000 units |
| Distribution | Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.