Class II — Invacare Corporation
| Recalling firm | Invacare Corporation dba Invacare America |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| Product | lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow. |
| Quantity | 395 |
| Distribution | Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand. |
| Initiated | 2016-06-21 |
| Classified | 2016-08-08 |
| Terminated | 2017-02-07 |
| Recall number | Z-2364-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Invacare Corporation (Z-2364-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74581/
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