Microline ReNew Reusable Grasper and Dissector Tips Recalled for Insulation Failure
Microline Surgical is recalling ReNew Reusable Grasper and Dissector Tips because heat-shrink insulation may split during sterilization, posing a burn risk during surgery.
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 (burn injury) where injury has not yet been reported, fitting the 'High' severity criteria for FDA Class II recalls without confirmed adverse events.
Plain-English summary
Microline Surgical, Inc. is recalling 61,769 units of ReNew Reusable Grasper and Dissector Tips. These medical devices are used with ReNew Laparoscopic Handpieces for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures. The affected units were distributed nationwide in the United States and in 21 other countries, including Australia, Brazil, Canada, and China.
The recall is due to a defect where the heat-shrink insulation tube may split during autoclave sterilization or re-sterilization. If the insulation splits, the heat-shrink material could fall off during a surgical procedure. If cautery is required during the procedure, this insulation failure creates a potential for patient burn injury.
Healthcare facilities and distributors should stop using the affected ReNew Reusable Grasper and Dissector Tips immediately. The recall covers all lots of specific product codes, including 3201 through 3431, as detailed in the agency's recall notice. Users should contact Microline Surgical, Inc. for instructions on returning or replacing the devices.
The recalled product
- Product
- The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Manufacturer
- Microline Surgical, Inc.
- Affected units
- 61,769
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 (20)
- All lots of product codes: 3201
- 3221
- 3231
- 3241
- 3251
- 3261
- 3271
- 3281
- 3291
- 3301
- 3311
- 3321
- 3331
- 3341
- 3351
- 3361
- 3371
- 3381
- 3401
- 3411
Distribution
Distributed nationwide across the United States.
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