FDA Medical Device Recalls (openFDA)
Primus Medical LLC: 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.
- Recall number
- Z-2596-2014
- Recalling firm
- Primus Medical LLC
- 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.
- Status
- Terminated
- Initiated
- 2014-08-11
- Posted
- 2014-09-09
- Terminated
- 2017-07-19
- Reason
- The firm found that the top cover of the mattresses were delaminating.
- Root cause
- Component design/selection
- Action
- The firm sent out Urgent: Voluntary Field Correction/Removal letters, dated August 11, 2014, to all consignees with instructions for correcting the issue. Customers were to immediately examine their inventory and quarantine any affected product. Customers are to complete and return the response form provided. Questions can be directed to 1-877-638-2776.
- Quantity
- 1,557 units
- Distribution
- Worldwide Distribution -- USA, including the states of TX, OH, PA, KS, FL, NV, IL, WA, MN, NJ, NC, UT, NY, CA, MD, CO. NE VA, and AZ; and, the country of Canada.
- Lot, serial or model codes
- Lot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMW
- Firm FEI
- 3007538326
- Firm city
- Boardman
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28