Fisher & Paykel Healthcare reusable breathing circuit — Class I medical device recall Z-0621-2013
Terminated recall by Fisher & Paykel Healthcare, Ltd., reported 2013-01-09, distributed in AR, GA, IL, IN. FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorpo
| Recall number | Z-0621-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher & Paykel Healthcare, Ltd., North Shore City, N/A, New Zealand |
| Recall initiated | 2012-11-19 |
| Classified | 2013-01-03 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2013-07-11 |
| Distributed | AR, GA, IL, IN |
| Reason classes | packaging |
| Lot numbers | 110810, 111020 |
Product
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Reason for recall
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
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-0621-2013. 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.