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.
What this means for you
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.
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