SCM True Air Technologies Recalls JK Bariatric Beds for Design Control Failures
SCM True Air Technologies is recalling 24 JK Bariatric Beds nationwide due to lack of design controls, missing Device Master Records, and unapproved vendors.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard stems from quality control failures (lack of design controls and vendor approval) rather than a specific, reported physical defect causing harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
SCM True Air Technologies LLC is recalling 24 JK Bariatric Beds distributed nationwide, including in Georgia, Kentucky, and Michigan. The recall is being conducted because the firm failed to maintain adequate design controls, lacked a Device Master Record, and failed to approve specific vendors.
The affected units are identified by the following serial numbers: 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, and 4735.
The source text does not specify specific consumer actions or report any illnesses or injuries associated with these devices.
The recalled product
- Product
- JK Bariatric Beds, True Air Technologies, Inc.
- Manufacturer
- SCM True Air Technologies LLC
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial #'s 41160
- 10127
- 09504
- 41918
- 106800
- 62188
- 106805
- 42331
- 106751
- 00234A
- 62422
- 7987
- 50147
- 7111
- 11151100
- BB111
- 00284A
- 2171269
- 62383
- 4731
Distribution
Part of a larger recall action
This product is one of 3 recalled by SCM True Air Technologies LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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