Intersurgical One-Piece Guedel Airway Recall
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Intersurgical Inc. is recalling 1,575 units of One-Piece Guedel Airway devices due to potential occlusion.
The full picture behind this FDA recall
This notice was issued by FDA on September 8, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Devices could potentially be occluded or partially occluded.", distributed us nationwide distribution in the states of ct, fl, in, mi, oh & va.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, Medical Devices.
What Happened
Intersurgical Inc. initiated a voluntary recall of certain One-Piece Guedel Airway devices after determining that the devices could potentially be occluded or partially occluded.
Which Products Are Affected
The recall affects the One-Piece Guedel Airway, size 000, ISO 3.5, Light Green, Oropharyngeal Airway Device. Product details include REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; and Lot Nos. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565. A total of 1,575 units are involved. Distribution was limited to the states of CT, FL, IN, MI, OH, and VA.
What You Should Do
Consumers should refer to the FDA recall notice for guidance on affected devices.
Why This Matters
The Class II recall involves a medical device distributed across multiple U.S. states.
Source
FDA recall number Z-2953-2026 (event ID 99284).
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (904 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 8, 2026.
Common Questions
Common questions about this FDA recall.