Z-0663-2025Class II

Microscissor Tip (Disposable); Microline Catalog #: 3122

Name: Z-0663-2025 Microscissor Tip (Disposable); Microline Catalog #: 3122
Creator: Microline Surgical, Inc.
Published: 2024-11-05
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2024-11-05 / Open, Classified

FDA source

Microline Surgical, Inc. began a recall of Microscissor Tip (Disposable); Microline Catalog #: 3122 on 2024-11-05. FDA classified it as Class II and gives the reason as "A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0663-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-05
Posted: 2024-12-10
Recalling firm: Microline Surgical, Inc
Product: Microscissor Tip (Disposable); Microline Catalog #: 3122.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
FDA 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. 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
Quantity in commerce: 200 units
Distribution: Worldwide - US Nationwide in the state of OK and the country of Japan.
Product codes and lots: Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0663-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0663-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-10

Product code GEI

K213127Class IIReNew Disposable Scissor TipsMicroline Surgical, Inc. / cleared 2022-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)