One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Intersurgical Inc · Devices could potentially be occluded or partially occluded.
Open FDA's page for this record- Cfres ID
- 221208
- Product res number
- Z-2953-2026
- Event date initiated
- 2026-06-15
- Event date posted
- 2026-08-14
- Recall status
- Open, Classified
- Res event number
- 99284
- Product code
- CAE
- Product description
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- Code info
- REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
- Firm FEI number
- 1000120301
- Recalling firm
- Intersurgical Inc
- Address 1
- 5010 Campuswood Dr Ste 102 5010 Campuswood Dr
- Address 2
- Ste 102
- City
- East Syracuse
- State
- NY
- Postal code
- 13057-1561
- Additional info contact
- Customer Support 800-828-9633
- Reason for recall
- Devices could potentially be occluded or partially occluded.
- Root cause description
- Process control
- Product quantity
- 1,575 units
- Distribution pattern
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- 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.
- Harmonized identifiers (openFDA)
- Device name
- Airway, Oropharyngeal, Anesthesiology
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5110
- Device class
- 1
- K number
- K810069, K881065, K821308, K953400, K833328, K862199, K883593, K861054, K913680, K842605, K871403, K844873, K822727, K904834, K832512, K892123, K880241, K890566, K832435, K130304, K033186, K830767, K841120, K820512, K854029, K861540, K922748, K960240, K780601, K891926, K891586, K933760, K892053, K810651, K855137, K760488, K860780, K850248, K831078, K021634 +17 more
- Registration number
- 3009093866, 3013412170, 3023809973, 1417592, 3007092328, 8043817, 9616354, 3007997596, 3010053546, 3015495690, 3005609751, 3013507143, 3006157842, 8022978, 3013528571, 3042617724, 3006783791, 1314417, 3010220595, 3032916566, 3004488394, 1250045, 3004111573, 2029275, 3004748541, 3010041511, 3006787036, 3006636962, 3005711994, 3021970868, 3004527595, 3032747418, 3008261717, 3011371465, 3012445994, 3030733800, 3004365956, 3006984712, 3010396739, 3018762668 +192 more
- FEI number
- 3009093866, 3013412170, 3023809973, 1417592, 3007092328, 3007997596, 3010053546, 3015495690, 3005609751, 3013507143, 3002808440, 3006157842, 3013528571, 3042617724, 3006783791, 1314417, 3010220595, 3032916566, 3004488394, 1250045, 3004111573, 3004748541, 3010041511, 3001044237, 3006787036, 3006636962, 3021970868, 3004527595, 3032747418, 3008261717, 3011371465, 3012445994, 3030733800, 3004365956, 3006984712, 3010396739, 3018762668, 3016458361, 3012777736, 3014829416 +192 more