Z-2953-2026Class II

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device

Name: Z-2953-2026 One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device
Creator: Intersurgical Inc
Published: 2026-06-15
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2026-06-15 / Open, Classified / root cause: manufacturing process

FDA source

Intersurgical Inc began a recall of One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device on 2026-06-15. FDA classified it as Class II and gives the reason as "Devices could potentially be occluded or partially occluded". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2953-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-15
Posted: 2026-08-14
Recalling firm: Intersurgical Ltd.
Product: One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: Devices could potentially be occluded or partially occluded.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 1,575 units
Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Product codes and lots: REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2953-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2952-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2953-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)