FDA Medical Device Recalls (openFDA)
Intersurgical Inc: One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
- Recall number
- Z-2276-2025
- Recalling firm
- Intersurgical Inc
- Product
- One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
- Status
- Open, Classified
- Initiated
- 2025-06-20
- Posted
- 2025-08-06
- Terminated
- not on file
- Reason
- Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
- Root cause
- Process control
- Action
- Intersurgical notified consignees on 06/20/2025 via email with recall letter. Consignees were instructed to immediately discontinue use and quarantine any affected units, immediately notify customers if product has been further distributed, arrange for the return of affected units and complete the Customer Product Recall Acknowledgement Form.
- Quantity
- 8,640 pieces
- Distribution
- US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
- Lot, serial or model codes
- Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAE
- Firm FEI
- 1000120301
- Firm city
- East Syracuse
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28