The Recall Desk
HighFDA (Devices)·Z-0690-2017·Announced 2016-12-07

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.

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 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.
Category
Medical Device — Surgical Instruments
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.

Related recalls

Same hazard · structural failure

See all →