Domain Surgical Recalls FMsealer Open Shears Due to Jaw Fractures
Domain Surgical is recalling FMsealer Open Shears (Model FM3001) because fixed jaw fractures were observed during clinical usage.
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 fracture) that poses a risk of harm during clinical usage, 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
Domain Surgical, Inc. is conducting a voluntary field action for the FMsealer Open Shears, Model FM3001. The recall is due to fixed jaw fractures that occurred during clinical usage.
The affected units were distributed nationwide and to other foreign consignees. The recall covers 70 units in the US and 175 units outside the US. The specific lots involved are 153411, 160321, 160531, 160991, 161311, 161442, 161871, and 162091. The source text does not list Canadian or VA/government/military consignees.
Healthcare providers should stop using the affected shears and contact Domain Surgical, Inc. for further instructions. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- FMsealer Open Shears. Model FM3001
- Manufacturer
- Domain Surgical, Inc.
- Hazard
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 (8)
- Lots: 153411
- 160321
- 160531
- 160991
- 161311
- 161442
- 161871
- 162091
Distribution
Distributed nationwide across the United States.
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