CLASS II Device recall · Reported 17 Sep 2014 · FDA Enforcement Report

Prime Plus ¿ Bariatric Mattress recalled by Primus Medical

Primus Medical is recalling Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, distributed in 19 states. The recall was initiated on 11 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113.

Quantity recalled1,557 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2596-2014
FDA event ID: 68805
Recalling firm: Primus Medical, Boardman, OH
Classification: Class II
Status: Terminated
Recall initiated: 11 Aug 2014
FDA classified: 9 Sep 2014
Reported: 17 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

11 Aug 2014	Recall initiated by company
9 Sep 2014	Classified by FDA	+29 days
17 Sep 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm found that the top cover of the mattresses were delaminating.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Arizona California Colorado Florida Illinois Kansas Maryland Minnesota North Carolina Nebraska New Jersey Nevada New York Ohio Pennsylvania Texas Utah Virginia Washington

Questions about this recall

Why was it recalled?

The firm found that the top cover of the mattresses were delaminating.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Primus Medical

All 3

Reported	Class	Recall	Company	Reason	Where
22 Oct 2014Device	CLASS II	AC Powered adjustable bed frame recalled by Primus Medical	Primus Medical	Other	Nationwide
14 Nov 2012Device	CLASS II	AC Powered adjustable hospital bed, Prime Bed TL500 recalled	Primus Medical	Other	Nationwide

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