SCM True Air Technologies Recalls ECATS E 850 Bariatric Beds
SCM True Air Technologies is recalling 48 ECATS E 850 Bariatric Beds due to manufacturing documentation and vendor approval failures.
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 documentation and vendor approval failures without reporting any injuries, illnesses, or specific mechanical hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
SCM True Air Technologies LLC is recalling 48 units of the ECATS E 850 Bariatric Bed. The recall was initiated by the U.S. Food and Drug Administration (FDA) and is classified as a Class II 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. These are quality control and documentation issues rather than reported mechanical failures or injuries.
The affected beds were distributed nationwide, including in Georgia, Kentucky, and Michigan. Consumers and healthcare facilities should check their serial numbers against the list provided by the FDA and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
- Manufacturer
- SCM True Air Technologies LLC
- Category
- Medical Device — Hospital Bed
- Affected units
- 48
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 E510
- 506
- 503
- 515
- 518
- 10050
- 512
- 519
- E9141
- E9150
- E9160
- E9149
- E9137
- E5107
- E9162
- E9165
- E9170
- E9147
- E5323
- E520
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
Same manufacturer · SCM True Air Technologies LLC
See all →- ModerateSCM True Air Technologies Recalls JK Bariatric Beds for Design Control Failures
FDA (Devices) · 2014-05-28
- ModerateSCM True Air Technologies Recalls MaXair Mattress Replacement Systems
FDA (Devices) · 2014-05-28
Same hazard · documentation error
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- SevereKreg Medical Recalls E-Z Wider Bariatric Chair Beds Due to Collapse
FDA (Devices) · 2013-06-12
- LowBoston Scientific Recalls Alair Bronchial Thermoplasty Catheters Due to Labeling Error
FDA (Devices) · 2013-07-24
- HighDREAMTOME Medical Device Recalled Due to Sterile Barrier Breach
FDA (Devices) · 2022-03-23
- HighETEST Clinical Erythromycin test plates recalled for storage temperature deviation
FDA (Devices) · 2023-01-11
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- HighClinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk
FDA (Devices) · 2015-02-04