ReNew recallZ-0663-2025 · Microline Surgical, Inc. · initiated Nov 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microline Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
FDA root cause category: Under Investigation by firm
What the company is doing
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. All products returned will be replaced at no cost. This recall is being done in an abundance of caution. No other item numbers or lots of ReNew Disposable Tips are affected by this recall. If you experience any adverse events or quality problems with the use of this product, please be sure to report this to the relevant Competent Authority s Adverse Event Reporting Program and to Microline as soon as possible. We regret any inconvenience and encourage you to contact Microline Customer Service at 978- 922-9810 or [email protected]. with any further questions. Actions to be taken by the Distributor: 1. Immediately determine if you are in possession of the products subject to this recall by checking the product name, item number, and lot number. 2. If you are a distributor of products subject to this recall, we require that you immediately remove affected products from inventory, quarantine products, and stop sales and shipping. 3. If you are a distributor and you have further distributed products subject to this recall, please identify customers immediately and notify them of this product recall using this Recall Notification Letter. Translation of this letter into local language is acceptable. We request that you direct your customers to return affected products to your facility for subsequent return to Microline. The relevant Competent Authority will be monitoring th
Recall details
- Recall number
- Z-0663-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 5, 2024
- Posted by the FDA
- Dec 10, 2024
- Recalling firm
- Microline Surgical, Inc.
- Quantity
- 200 units
- Product code
- GEI
- FDA submissions
- K213127
- Distribution
- Worldwide - US Nationwide in the state of OK and the country of Japan.
Product description
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Code information (models, lots, serial numbers)
Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ReNew 3122Microline Surgical, Inc. · Electrosurgical, Cutting & Coagulation & Accessories1 recall8 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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