CLASS II ONGOING Device recall · Reported 18 Dec 2024 · FDA Enforcement Report
Microscissor Tip (Disposable) recalled by Microline Surgical
Microline Surgical is recalling Microscissor Tip (Disposable), distributed nationwide in the US. The recall was initiated on 5 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0663-2025
- FDA event ID
- 95734
- Recalling firm
- Microline Surgical, Beverly, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Nov 2024
- FDA classified
- 10 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2024 | Recall initiated by company | |
| 10 Dec 2024 | Classified by FDA | +35 days |
| 18 Dec 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Where it was distributed
Worldwide - US Nationwide in the state of OK and the country of Japan.
Questions about this recall
Is Microscissor Tip (Disposable) recalled?
Yes. Microline Surgical recalled Microscissor Tip (Disposable) on 5 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0663-2025.
Why was it recalled?
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
Which lots are affected?
Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.
Where was it sold?
Worldwide - US Nationwide in the state of OK and the country of Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Microline Surgical
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TLS2 Thermal Ligating Shears recalled by Microline Surgical | Microline Surgical | Device Malfunction | ND, NY |
| Device | CLASS II | ReNew Dolphin Nose Disposable Dissector Tip recalled | Microline Surgical | Sterility | 5 states |
| Device | CLASS II | ReNew Endocut Scissor Disposable Tip recalled by Microline Surgical | Microline Surgical | Sterility | 5 states |
| Device | CLASS II | The ReNew Reusable Grasper and Dissector Tips are to be recalled | Microline Surgical | Sterility | Nationwide |
| Device | CLASS II | ReNew Laproscopic Fenestrated Grasper Forceps Tips recalled | Microline Surgical | Device Malfunction | 10 states |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |