Airways Development LLC WaterPAP Positive Airway Pressure Device… — Class II medical device recall Z-0552-2016
Terminated recall by Airways Development LLC, reported 2015-12-30, distributed nationwide. Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a re
| Recall number | Z-0552-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Airways Development LLC, Kenilworth, NJ, United States |
| Recall initiated | 2015-09-24 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,464 units |
| Reason classes | packaging |
| Lot numbers | 8605A |
Product
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Reason for recall
Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0552-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.