Microline Surgical ReNew Laproscopic Grasper Forceps Tips Recalled for Jaw Breakage
Microline Surgical is recalling 150 units of ReNew Laproscopic Fenestrated Grasper Forceps Tips because the jaw may break when force is applied.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the 'High' severity criteria for potential mechanical failure during use.
Plain-English summary
Microline Surgical, Inc. is recalling 150 units of ReNew Laproscopic Fenestrated Grasper Forceps Tips, Reference 3221, Lot Number 00115342. The recall is due to a potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw.
The affected products were distributed worldwide, including in the United States (specifically CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX) and in Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and the UK.
Healthcare facilities and users should stop using the affected forceps tips and contact Microline Surgical, Inc. for further instructions on the recall.
The recalled product
- Product
- Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
- Manufacturer
- Microline Surgical, Inc.
- Hazard
- Affected units
- 150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 00115342
Distribution
Part of a larger recall action
This product is one of 2 recalled by Microline Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Microline Surgical, Inc.
See all →- HighReNew Microscissor Tip Disposable Recalled Due to Heat Shrink Failure
FDA (Devices) · 2024-12-18
- HighMicroline TLS2 Thermal Ligating Shears Recalled for Actuation Failure
FDA (Devices) · 2019-06-12
- HighMicroline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns
FDA (Devices) · 2018-05-16
- HighMicroline Surgical Recalls ReNew Dolphin Nose Disposable Dissector Tips
FDA (Devices) · 2018-05-16
- HighMicroline ReNew Reusable Grasper and Dissector Tips Recalled for Insulation Failure
FDA (Devices) · 2018-02-14
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighMicroline Renew Fenestrated Control Tip Grasper Recalled for Jaw Breakage
FDA (Devices) · 2014-05-28
- HighMicroline ReNew Reusable Grasper and Dissector Tips Recalled for Insulation Failure
FDA (Devices) · 2018-02-14
- HighMicroline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns
FDA (Devices) · 2018-05-16
- HighReNew Microscissor Tip Disposable Recalled Due to Heat Shrink Failure
FDA (Devices) · 2024-12-18
- HighTeleflex Percuvance Johans Grasper Tool Tip Recall for Connection and Jaw Issues
FDA (Devices) · 2017-10-04
- HighFenestrated Graspers Recalled Due to Potential Breakage and Fragment Risk
FDA (Devices) · 2023-07-12