CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report
P.R.O. Matt: (a) Promatt Plus Matress, Nylon recalled
Joerns Healthcare is recalling P.R.O. Matt: (a) Promatt Plus Matress, Nylon, Material Number PMP3676NZBA (b) Promatt, distributed nationwide in the US. The recall was initiated on 3 May 2018 and the FDA has classified it as Class II.
Check your package
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-2033-2018
- FDA event ID
- 80113
- Recalling firm
- Joerns Healthcare, Arlington, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2018
- FDA classified
- 30 May 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 May 2018 | Recall initiated by company | |
| 30 May 2018 | Classified by FDA | +27 days |
| 6 Jun 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
Product as listed by the FDA
P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
Where it was distributed
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
Questions about this recall
Why was it recalled?
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
Which lots are affected?
P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA; Serial Numbers: 1000057154 1000057153 (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA; Serial Numbers: 1000051430 1000051425 1000051366 1000051422 1000056411 1000058530 1000056414 (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA; Serial Numbers: 1000049130 1000054638 1000054639 (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA; Serial Numbers: 1000057195 1000055122 1000055401 1000057190 1000055328 1000054681 1000057193 1000057171 1000051436 1000055326 1000054386 1000054387 1000054385 1000051441 1000051432 1000051439 1000054936 1000054144 1000054935 1000054390 1000054368 1000051440 1000054932 1000055059 1000055134 1000055070 1000055058 1000055118 1000054872 1000055317 1000055130 1000055074 1000055313 1000055093 1000054906 1000055091 1000055132 1000055068 1000054926 1000054922 1000055065 1000054373 1000055062 1000055329 1000054140 1000054868 1000055319 1000054683 1000051437 1000055111 1000049127 1000054927 1000054380 1000054375 1000052270 1000054383 1000054940 1000053404 1000054143 1000054915 1000054917 1000054379 1000054389 1000054924 1000054941 1000055114 1000054378 1000055316 1000054377 1000055337 1000054933 1000051367 1000054371 1000054388 1000052267 1000054142 1000055332 1000057169 1000057860 1000054907 (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA; Serial Numbers: PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA; Serial Numbers: PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA; Serial Numbers: PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT; Serial Numbers: PMPE3480SZBADT PMPE3480SZBADT PMPE3480SZBADT
Where was it sold?
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
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.
Other products in this recall event
1 other product · FDA event 80113| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ProCair Mattress: (a) Procair Plus recalled by Joerns Healthcare | Joerns Healthcare | Other | Nationwide |
More recalls from Joerns Healthcare
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ProCair Mattress: (a) Procair Plus recalled by Joerns Healthcare | Joerns Healthcare | Other | Nationwide |
| Device | CLASS II | Joerns EasyCare Bed recalled by Joerns Healthcare | Joerns Healthcare | Device Malfunction | Nationwide |
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