Airways Development Recalls WaterPAP Positive Airway Pressure Devices
Airways Development LLC is recalling 1,464 WaterPAP Positive Airway Pressure Devices due to a reported canister leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a reported defect (leaking canister) that poses a risk of harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Airways Development LLC is recalling 1,464 units of the WaterPAP Positive Airway Pressure Device, Reference #WP-7700, Lot 8605A. The recall was initiated after the company received a complaint regarding a canister leaking from the device.
The devices were distributed nationwide. During a review with their supplier, Airways Development LLC could not determine if the leak was an isolated incident or if the entire lot is impacted.
Consumers should stop using the affected devices and contact Airways Development LLC for further instructions.
The recalled product
- Product
- Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
- Manufacturer
- Airways Development LLC
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 1,464
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Reference #WP-7700
- Lot 8605A
Distribution
Distributed nationwide across the United States.
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