SCM True Air Technologies LLC: Medical Device Recall in 2014 - (Recall #: Z-1630-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

JK Bariatric Beds, True Air Technologies, Inc.

Product Classification:

Class II

Date Initiated: March 18, 2014

Date Posted: May 28, 2014

Recall Number: Z-1630-2014

Event ID: 67924

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.

Status: Terminated

Product Quantity: 24 beds

Code Information:

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

Distribution Pattern:

Nationwide Distribution including GA, KY, and MI.

Voluntary or Mandated:

Voluntary: Firm initiated