Official recall notice

FDA DeviceClass IINotable

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

Recall date
2026-08-26
FDA class
Class II

Why it was recalled

Hazard

Devices could potentially be occluded or partially occluded.

Product description

Devices could potentially be occluded or partially occluded.

Affected products

REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.

Verify with the official notice →
Share:

Related Recalls

2026-09-16 · FDA_DEVICE
FDA Recall: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Windstone Medical Packaging, Inc.
2026-09-16 · FDA_DEVICE
FDA Recall: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2
Atrium Medical Corporation
2026-09-16 · FDA_DEVICE
FDA Recall: Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Nipro Renal Soultions USA, Corporation
2026-09-16 · FDA_DEVICE
FDA Recall: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Nipro Renal Soultions USA, Corporation