Microline TLS2 Thermal Ligating Shears Recalled for Actuation Failure
Microline Surgical is recalling 115 TLS2 Thermal Ligating Shears because they fail to actuate, preventing them from performing their intended surgical function.
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. The hazard involves a medical device failing to perform its intended function during surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Microline Surgical, Inc. is recalling 115 units of TLS2 Thermal Ligating Shears, Catalog Number 132-131D. The recall affects specific lot numbers (807118, 807119, 807120, 811076) and UDI 811099011439.
The recall was initiated because the shears exhibited a high rate of complete or intermittent failure to actuate. As a result, the devices do not perform their intended function in surgical procedures.
The products were distributed to the US states of North Dakota and New York, as well as to Germany and the Netherlands. Healthcare facilities and users should stop using the affected devices and contact Microline Surgical for instructions on return or replacement.
The recalled product
- Product
- TLS2 Thermal Ligating Shears, Catalog Number 132-131D
- Manufacturer
- Microline Surgical, Inc.
- Hazard
- Affected units
- 115
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 (5)
- UDI: 811099011439
- Lot Numbers: 807118
- 807119
- 807120
- 811076
Distribution
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