FDA Medical Device Recalls (openFDA)
SCM True Air Technologies LLC: JK Bariatric Beds, True Air Technologies, Inc.
- Recall number
- Z-1630-2014
- Recalling firm
- SCM True Air Technologies LLC
- Product
- JK Bariatric Beds, True Air Technologies, Inc.
- Status
- Terminated
- Initiated
- 2014-03-18
- Posted
- 2014-05-19
- Terminated
- 2018-06-11
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- SCM True Air Technologies LLC sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from use and return to True Air Technologies immediately. The units should be decontaminated and bagged with a certification of disinfection before return to True Air Technologies. True Air will provide replacement units to replace the returned units. Customers were instructed to refer to the Medical Device Recall Return Response Form attached for acknowledgement of receipt and contact information for this voluntary recall. Customers with questions should call 800-682-7163.
- Quantity
- 24 beds
- Distribution
- Nationwide Distribution including GA, KY, and MI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OSI
- Firm FEI
- 3001452084
- Firm city
- Louisville
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28