CLASS II Device recall · Reported 20 May 2015 · FDA Enforcement Report
ReTurn belt, wipeable, sizes Small through Extra Large recalled
Handicare USA is recalling ReTurn belt, wipeable, sizes Small through Extra Large, 1, distributed in California, Florida, Maryland, North Carolina, New Jersey. The recall was initiated on 26 Mar 2015 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-1613-2015
- FDA event ID
- 70995
- Recalling firm
- Handicare USA, Allentown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2015
- FDA classified
- 14 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 26 Mar 2015 | Recall initiated by company | |
| 14 May 2015 | Classified by FDA | +49 days |
| 20 May 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
Where it was distributed
US Distribution to the states of : FL, CA, NJ, NC and MD.
Questions about this recall
Is ReTurn belt, wipeable, sizes Small through Extra Large, 1 recalled?
Yes. Handicare USA recalled ReTurn belt, wipeable, sizes Small through Extra Large, 1 on 26 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1613-2015.
Why was it recalled?
Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
Which lots are affected?
All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
Where was it sold?
US Distribution to the states of : FL, CA, NJ, NC and MD.
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 21 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 Handicare USA
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|---|---|---|---|---|---|
| Device | CLASS II | Handicare P600 Series Patient Lift recalled | Handicare Usa | Device Malfunction | Nationwide |
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