Food, drugs, devices › Primus Medical LLC
Device recall: Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Pr
Primus Medical LLC (Boardman, OH) initiated this device recall on 11 Aug 2014; FDA lists 1 product record under event 68805, classified Class II.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 19 Jul 2017. Initiation: voluntary: firm initiated. Primus Medical LLC has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Primus Medical LLC, Boardman, OH.
Reason for recall
"The firm found that the top cover of the mattresses were delaminating."
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2596-2014 | 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,… | 1,557 units | Class II | Terminated | 17 Sep 2014 |
Context
Other enforcement events for Primus Medical LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Sep 2014 | AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities. | Device | Class II | 1 |
| 2 Feb 2011 | AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, O | Device | Class II | 1 |
All 3 events for Primus Medical LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm found that the top cover of the mattresses were delaminating."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Jul 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.