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Intersurgical One-Piece Guedel Airway
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MEDICAL DEVICE RECALLMODERATE

Intersurgical One-Piece Guedel Airway

Intersurgical recalls One-Piece Guedel Airway, size 00, ISO 5.0, Blue, due to potential occlusion.

What to do

Stop using the affected airway device immediately and contact Intersurgical Inc for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2953-2026
Agency
FDA
Firm
Intersurgical Inc
Recall ID
99284
Status
ONGOING

Why it was recalled

Intersurgical Inc is recalling One-Piece Guedel Airway devices, size 00, ISO 5.0, Blue, because the devices could potentially be occluded or partially occluded.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

One-Piece Guedel Airway, size

ProductLot codeRecall #UDI-DI
000, ISO 3.5, Light Green. Oropharyngeal Airway Device.32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565Z-2953-20265030267049844, 05030267044528, 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565
00, ISO 5.0, Blue. Oropharyngeal Airway Device.32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154Z-2952-20265030267050185, 05030267044450, 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification