MaXair True Low Air Loss Mattress Replacement System — Class II medical device recall Z-1632-2014
Terminated recall by SCM True Air Technologies LLC, reported 2014-05-28, distributed nationwide. The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure
| Recall number | Z-1632-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCM True Air Technologies LLC, Louisville, KY, United States |
| Recall initiated | 2014-03-18 |
| Classified | 2014-05-18 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2018-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 83 units |
| Serial numbers | 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2061, 2062, 2063, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2081 and 57 more |
Product
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Reason for recall
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
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-1632-2014. 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.