ProCair Mattress: — Class II medical device recall Z-2034-2018
Terminated recall by Joerns Healthcare, reported 2018-06-06, distributed nationwide. Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For th
| Recall number | Z-2034-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Joerns Healthcare, Arlington, TX, United States |
| Recall initiated | 2018-05-03 |
| Classified | 2018-05-30 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2023-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, NL |
| Quantity | 46 units |
| Serial numbers | 1000049129, 1000049132, 1000051368, 1000051411, 1000051412, 1000051418, 1000051419, 1000052252, 1000052256, 1000052259, 1000052420, 1000052424, 1000052425, 1000052426, 1000052429, 1000052432, 1000052455, 1000052457, 1000052458, 1000052460, 1000052886, 1000052888, 1000052891, 1000053312, 1000053319 and 21 more |
Product
ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
Reason for recall
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
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-2034-2018. 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.