Microline Surgical ReNew Laproscopic Grasper Forceps Tips Recalled for Jaw Breakage
Microline Surgical is recalling 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 is classified as FDA Class II, and the hazard involves a mechanical failure (jaw breakage) in a surgical instrument which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Microline Surgical, Inc. is recalling 6,290 units of ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable), Reference 3222. 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 California, Hawaii, Idaho, Massachusetts, Michigan, Mississippi, Pennsylvania, Tennessee, Utah, and Texas) and in Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and the United Kingdom. The recall covers specific lot numbers: 00115282, 00115283, 00115284, 00115340, 00115341, 00115501, 00115502, 00115865, 00116277, and 00116278.
Healthcare providers and facilities should stop using the affected forceps tips and contact Microline Surgical, Inc. for instructions on return or replacement.
The recalled product
- Product
- Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
- Manufacturer
- Microline Surgical, Inc.
- Hazard
- Affected units
- 6,290
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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