One-Piece Guedel Airway, size 000, ISO 3.5, Light Green.… recallZ-2953-2026 · Intersurgical Inc · initiated Jun 15, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intersurgical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices could potentially be occluded or partially occluded.
FDA root cause category: Process control
What the company is doing
An URGENT MEDICAL DEVICE RECALL notification dated 6/12/26 was mailed and to consignees. The notification instructs consignees to immediately discontinue use of affected devices and quarantine any stock remaining. If product has been further distributed a copy of the recall notification is to be forwarded and collect their affected product. To coordinate return of goods contact Intersurgical Customer Support at 800-828-9633 from Monday through Thursday, 8:00 AM to 3:00 PM EST, and follow the provided instructions.
Recall details
- Recall number
- Z-2953-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 15, 2026
- Posted by the FDA
- Aug 14, 2026
- Recalling firm
- Intersurgical Inc
- Quantity
- 1,575 units
- Product code
- CAE
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Product description
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Code information (models, lots, serial numbers)
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GUEDEL AIRWAY, SIZE 000, ISO 3.5 1000035Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99284).
- Z-2952-2026 · Open, ClassifiedOne-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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