The Recall Desk
HighFDA (Devices)·Z-0552-2016·Announced 2015-12-30

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.

What this means for you

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.
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.