FDA Device recall Z-1630-2014
JK Bariatric Beds, True Air Technologies, Inc
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of JK Bariatric Beds, True Air Technologies, Inc by Scm True Air Technologies, citing the firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1630-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-18 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Scm True Air Technologies |
| Distribution | US |
Product
JK Bariatric Beds, True Air Technologies, Inc.
Reason
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Identifiers
| code_info | Serial #'s 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100…Serial #'s 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, 4735 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1630-2014%22
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