The Recall Desk
ModerateFDA (Devices)·Z-2596-2014·Announced 2014-09-17

Primus Medical Recalls Transcend and Bariatric Mattresses Due to Delamination

Primus Medical LLC is recalling specific Transcend and Bariatric mattresses because the top cover is delaminating. The recall affects 1,557 units distributed in the US and Canada.

What this means for you

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 illnesses. The defect is a structural delamination of the cover, which is a moderate risk without reported harm.

Plain-English summary

Primus Medical LLC is recalling specific models of Prime Care Transcend and Prime Plus Bariatric mattresses. The recall involves 1,557 units, including models TCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284, TACM3576, TACM3580, TACM3580P, TACM3584, PPBM396, PPBM426, PPBM426P, PPBM486, PPBM546, PPBM397, PPBM427, and PPBM487. The affected units are identified by lot numbers 031512, 032912, 041712, 041812, 060412, 061312, 061412, 071312, 080912, 032713, 053013, and 053113.

The firm determined that the top cover of the mattresses was delaminating. These mattresses are intended to protect the inner foam layers from fluids. The affected units were distributed worldwide, specifically in the United States (including TX, OH, PA, KS, FL, NV, IL, WA, MN, NJ, NC, UT, NY, CA, MD, CO, NE, VA, and AZ) and Canada.

Consumers should contact Primus Medical LLC for further instructions regarding the recall. The source text does not specify a particular remedy or contact method, so users should refer to the official recall notice for details.

The recalled product

Product
Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged seper
Manufacturer
Primus Medical LLC
Category
Medical Device — Mattresses
Hazard
Affected units
1,557

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 (12)

  • Lot numbers: 031512
  • 032912
  • 041712
  • 041812
  • 060412
  • 061312
  • 061412
  • 071312
  • 080912
  • 032713
  • 053013
  • and 053113.

Distribution

Distributed in 18 states:

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