Device recall: JK Bariatric Beds, True Air Technologies, Inc.
Class II FDA enforcement event 67924. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
SCM True Air Technologies LLC started this device recall on 18 Mar 2014. The firm address in the FDA record is in Louisville, KY. FDA put the recall in Class II. FDA event 67924 has 3 product records. The first FDA enforcement report date is 28 May 2014. The record gives the status Terminated, with the termination date 11 Jun 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution including GA, KY, and MI.
Recalling firm
SCM True Air Technologies LLC, Louisville, KY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1630-2014 | JK Bariatric Beds, True Air Technologies, Inc. | 24 beds | Class II | Terminated | 28 May 2014 |
| Z-1631-2014 | ECATS E 850 Bariatric Bed, True Air Technologies, Inc. | 48 beds | Class II | Terminated | 28 May 2014 |
| Z-1632-2014 | MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc. | 83 units | Class II | Terminated | 28 May 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 3
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1630-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67924. https://recallregister.com/fda/ii/67924/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution including GA, KY, and MI.
- What quantity of product is in FDA event 67924?
- The event has 3 product records. The first record gives this quantity:
24 beds
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.