CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
EMS products from Graham Medical recalled by Little Rapids
Little Rapids is recalling EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, distributed in 9 states. The recall was initiated on 27 Dec 2017 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-0578-2018
- FDA event ID
- 78899
- Recalling firm
- Little Rapids, Green Bay, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2017
- FDA classified
- 9 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Dec 2017 | Recall initiated by company | |
| 9 Feb 2018 | Classified by FDA | +44 days |
| 21 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.
Product as listed by the FDA
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Where it was distributed
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
CaliforniaConnecticutFloridaMissouriMississippiSouth DakotaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.
Which lots are affected?
Lot codes: 17871, 17971, 18071, and 18971
Where was it sold?
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
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.
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