Guedel Airway Recalled Due to Potential Small Burr Contamination
Intersurgical Inc is recalling 2,800 Guedel airways (Model 1112080, Lot 32414447) due to potential small burrs that could detach and be inhaled, causing airway obstruction or tissue damage. No injuries have been reported.
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: This is a Class II medical device recall involving a risk-of-harm airway product with no reported illnesses, injuries, or deaths. Per FDA severity criteria, theoretical contamination risks in safety-critical devices without reported incidents warrant a High severity score.
Plain-English summary
Intersurgical Inc is recalling 2,800 one-piece Guedel airways, size 2, ISO 8.0, green (Model Number 1112080, Lot 32414447) distributed across multiple US states.
The airway devices may contain small burrs that could detach during use. If inhaled, these burrs could cause airway obstruction, tissue irritation, inflammation, and infection.
The recalled units were distributed to Arizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah, and Virginia. Healthcare providers and facilities that received these devices should stop using them immediately.
If you have received this product, cease use and contact Intersurgical Inc or the FDA. No injuries or illnesses related to this defect have been reported to date.
The recalled product
- Product
- One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
- Manufacturer
- Intersurgical Inc
- Hazard
- burr-contamination
- airway-obstruction
- inhalation-hazard
- infection-risk
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 (2)
- Model Number: 1112080. UDI-DI (Case): 05030267040698
- UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
Distribution
Distributed in 10 states:
- AZ
- CA
- CT
- FL
- HI
- MA
- MI
- OH
- UT
- VA
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