CLASS II Device recall · Reported 28 May 2014 · FDA Enforcement Report
JK Bariatric Beds, True Air Technologies, Inc recalled
SCM True Air Technologies is recalling JK Bariatric Beds, True Air Technologies, Inc, distributed nationwide in the US. The recall was initiated on 18 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1630-2014
- FDA event ID
- 67924
- Recalling firm
- SCM True Air Technologies, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2014
- FDA classified
- 18 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Mar 2014 | Recall initiated by company | |
| 18 May 2014 | Classified by FDA | +61 days |
| 28 May 2014 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
JK Bariatric Beds, True Air Technologies, Inc.
Where it was distributed
Nationwide Distribution including GA, KY, and MI.
Questions about this recall
Is JK Bariatric Beds, True Air Technologies, Inc recalled?
Yes. SCM True Air Technologies recalled JK Bariatric Beds, True Air Technologies, Inc on 18 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1630-2014.
Why was it recalled?
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Which lots are affected?
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
Where was it sold?
Nationwide Distribution including GA, KY, and MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SCM True Air Technologies
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ecats E 850 Bariatric Bed, True Air Technologies, Inc recalled | SCM True Air Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | MaXair True Low Air Loss Mattress Replacement System recalled | SCM True Air Technologies | Device Malfunction | Nationwide |
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