Recall Z-0663-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Microline Surgical, Inc.
Microscissor Tip (Disposable); Microline Catalog #: 3122.
| Date | Dec 10, 2024 (initiated Nov 5, 2024) |
| Status | Open, Classified |
| Reason | A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off. |
| Root cause | Under Investigation by firm |
| Action | On November 6, 2024 URGENT: MEDICAL DEVICE RECALL letters were sent to consignees. Actions to be taken by the Customer/User: Please locate those products you have that correspond with the above identified lots, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall |
| Quantity | 200 units |
| Distribution | Worldwide - US Nationwide in the state of OK and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213127 | ReNew Disposable Scissor Tips Microline Surgical, Inc., Mar 2, 2022 |