Sterilmed Recalls Reprocessed Microline Scissor Tips Due to Manufacturing Defect
Sterilmed is recalling 11,326 reprocessed Microline Scissor Tips due to a potential manufacturing defect that could result in patient injury.
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 involves a potential manufacturing defect that could result in patient injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Sterilmed, Inc. is recalling 11,326 units of reprocessed Microline Scissor Tips. These devices are intended to be used with a reusable hand piece for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. The affected models include MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, and MIC3162.
The recall is being conducted because of a potential manufacturing defect that can possibly result in patient injury. The agency has classified this recall as Class II. The affected units were distributed to 28 states in the United States and Canada.
Healthcare facilities and consumers should stop using the affected Scissor Tips immediately. Users should check their inventory for the specific model numbers and lot numbers listed in the official recall notice. Sterilmed is the recalling firm responsible for this action.
The recalled product
- Product
- Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152…
- Manufacturer
- STERILMED, INC.
- Affected units
- 11,326
Distribution
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