High FDA (Devices)·Z-2276-2025·Announced 2025-08-13

Guedel airways may carry small burrs that could detach and be inhaled

One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.

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: Risk-of-harm product: burrs on an airway device that could detach and be inhaled, causing obstruction, with no injury reported in the source.

Plain-English summary

The one-piece Guedel airway, size 3, ISO 9.0, yellow, model number 1113090, is being recalled. The action covers 8,640 pieces, with case UDI-DI 05030267153961 and single unit UDI-DI 5030267050680.

The stated reason is potential contamination with small burrs, which if they detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was in Arizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah and Virginia. The airways are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the model number, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product: One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Manufacturer: Intersurgical Inc
Category: Medical Device — Oropharyngeal airway
Hazard: burrs
inhalation-hazard
airway-obstruction
class-ii
Affected units: 8,640

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: 1113090. UDI-DI (Case): 05030267153961
UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 2 recalled by Intersurgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Intersurgical Inc

See all →

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Intersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk
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Same hazard · burrs