Recall Z-0922-2026 ยท LRW Scissors, General, Surgical
Medline Industries, LP
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
| Date | Dec 12, 2025 (initiated Nov 13, 2025) |
| Status | Open, Classified |
| Reason | The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. |
| Root cause | Packaging process control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 11/13/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please complete and return the enclosed response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Your account will receive |
| Quantity | 53 units |
| Distribution | US Nationwide distribution in the states CA, CO, IL, KS, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.