FDA Medical Device Recalls (openFDA)
Intersurgical Inc: One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
- Recall number
- Z-2952-2026
- Recalling firm
- Intersurgical Inc
- Product
- One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
- Status
- Open, Classified
- Initiated
- 2026-06-15
- Posted
- 2026-08-14
- Terminated
- not on file
- Reason
- Devices could potentially be occluded or partially occluded.
- 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
- 21,269 units
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Lot, serial or model codes
- REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.
- 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