Prime Care ¿ Transcend Mattress — Class II medical device recall Z-2596-2014
Terminated recall by Primus Medical LLC, reported 2014-09-17, distributed in AZ, CA, CO, FL, IL, KS, MD, MN…. The firm found that the top cover of the mattresses were delaminating.
| Recall number | Z-2596-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Primus Medical LLC, Boardman, OH, United States |
| Recall initiated | 2014-08-11 |
| Classified | 2014-09-09 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2017-07-19 |
| Distributed | AZ, CA, CO, FL, IL, KS, MD, MN, NC, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA |
| Countries outside the US | CA |
| Quantity | 1,557 units |
| Lot numbers | 031512, 032713, 032912, 041712, 041812, 053013, 053113, 060412, 061312, 061412, 071312, 080912 |
| Model numbers | PPBM396, PPBM397, PPBM426, PPBM426P, PPBM427, PPBM486, PPBM487, PPBM546, TACM3576, TACM3580, TACM3580P, TACM3584, TCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284 |
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 seperately. Model Numbers: TCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284, TACM3576, TACM3580, TACM3580P, TACM3584, PPBM396, PPBM426, PPBM426P, PPBM486, PPBM546, PPBM397, PPBM427, and PPBM487. Intended to protect inner foam layers of mattress from any fluids that may be on the mattress.
Reason for recall
The firm found that the top cover of the mattresses were delaminating.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2596-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.