The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1632-2014·Announced 2014-05-28

SCM True Air Technologies Recalls MaXair Mattress Replacement Systems

SCM True Air Technologies is recalling 83 MaXair True Low Air Loss Mattress Replacement Systems due to design control and documentation deficiencies.

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 cites only documentation and process failures (lack of design controls, Device Master Record, and vendor approval) without reporting any specific physical defects, injuries, or illnesses. This aligns with the rubric for moderate severity involving minor or theoretical risks.

Plain-English summary

SCM True Air Technologies LLC is recalling 83 units of the MaXair True Low Air Loss Mattress Replacement System. The recall was initiated due to a lack of design controls, a lack of a Device Master Record, and a failure to approve specific vendors.

The affected units were distributed nationwide, including in Georgia, Kentucky, and Michigan. The recall covers specific serial numbers ranging from 2054 to 2150, with gaps in the sequence as listed in the official notice.

Consumers and healthcare facilities should stop using the affected units and contact SCM True Air Technologies for instructions on how to proceed with the recall.

The recalled product

Product
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Manufacturer
SCM True Air Technologies LLC
Category
Medical Device — Mattress System
Hazard
Affected units
83

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 2054
  • 2055
  • 2056
  • 2057
  • 2058
  • 2059
  • 2060
  • 2061
  • 2062
  • 2063
  • 2067
  • 2068
  • 2069
  • 2070
  • 2071
  • 2072
  • 2073
  • 2074
  • 2075
  • 2076

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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

Same manufacturer · SCM True Air Technologies LLC

See all →

Same hazard · documentation deficiency

See all →

Similar recalls