One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Summary
The FDA issued a Class II for One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway De by Intersurgical Inc. Reason: Devices could potentially be occluded or partially occluded..
Details
Source
Device Recall
External ID
Z-2953-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Lot/Code Info: REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Quantity Affected: 1,575 units
Reason for Recall
Devices could potentially be occluded or partially occluded.
Distribution
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-15
Company
East Syracuse, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Intersurgical Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intersurgical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intersurgical Inc have FDA actions?
Intersurgical Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2953-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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