Recall Z-2953-2026
Intersurgical Inc · initiated June 15, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Codes / lots: REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Reason for recall
Devices could potentially be occluded or partially occluded.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2953-2026
- Initiated
- June 15, 2026
- Posted by FDA
- August 14, 2026
- Product code
- CAE – Airway, Oropharyngeal, Anesthesiology
- Quantity
- 1,575 units
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Recalling firm
- Intersurgical Inc, East Syracuse, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2952-2026 Class II | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.Devices could potentially be occluded or partially occluded. | 06/15/2026Open, Classified |