Food, drugs, devices › Handicare USA, Inc.
Device recall: ReTurn 7500/7500 Aid, transfer
FDA enforcement event 75404 is a device recall by Handicare USA, Inc. of Allentown, PA, initiated 15 Apr 2014 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 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 13 Dec 2016. 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
"During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder."
Distribution
"US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0303-2017 | ReTurn 7500/7500 Aid, transfer | 29 units , plus 47 wing handles were shipped as spare parts | Class II | Terminated | 2 Nov 2016 |
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 |
| 26 Mar 2015 | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid. | 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: "During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder."
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 : NY, NJ, NV, NE, IL, CT, PA and ME"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Dec 2016. "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.