Microline Renew Fenestrated Control Tip Grasper Recalled for Jaw Breakage
Microline Surgical is recalling 540 units of Renew Fenestrated Control Tip Graspers 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 medical device with a structural defect (jaw breakage) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microline Surgical is recalling 540 units of the Microline Renew Fenestrated Control Tip Grasper, Product Number 3222. These single-patient-use instruments are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures.
The recall was initiated because the grasper jaw may break when force is applied to the jaw. The affected units are identified by Lot Numbers 00116169 and 00115866.
The products were distributed worldwide, including in the United States (specifically Texas, Illinois, Tennessee, and New York) and Chile. Users should stop using the affected devices and contact Microline Surgical for further instructions.
The recalled product
- Product
- Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where…
- Manufacturer
- Microline Surgical
- Affected units
- 540
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: 00116169 and 00115866
Distribution
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