Food, drugs, devices › Handicare USA, Inc.
Device recall: ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
FDA enforcement event 70995 is a device recall by Handicare USA, Inc. of Allentown, PA, initiated 26 Mar 2015 and classified Class II, with 1 product record.
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 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 17 Aug 2015. Initiation: voluntary: firm initiated. Handicare USA, Inc. has 4 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
Handicare USA, Inc., Allentown, PA.
Reason for recall
"Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied."
Distribution
"US Distribution to the states of : FL, CA, NJ, NC and MD."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1613-2015 | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid. | 64 | Class II | Terminated | 20 May 2015 |
Context
Other enforcement events for Handicare USA, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Nov 2017 | Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another. | Device | Class II | 2 |
| 8 Sep 2017 | PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered | Device | Class II | 1 |
| 15 Apr 2014 | ReTurn 7500/7500 Aid, transfer | Device | Class II | 1 |
All 4 events for Handicare USA, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied."
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: "US Distribution to the states of : FL, CA, NJ, NC and MD."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Aug 2015. "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.