FDA Medical Device Recalls (openFDA)
Handicare USA, Inc.: ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
- Recall number
- Z-1613-2015
- Recalling firm
- Handicare USA, Inc.
- Product
- ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
- Status
- Terminated
- Initiated
- 2015-03-26
- Posted
- 2015-05-14
- Terminated
- 2015-08-17
- Reason
- Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
- Root cause
- Device Design
- Action
- Handicare sent an Voluntary Product Recall Notification letter dated April 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to quarantine any remaining stock and to contact customers if product was further distributed and to return the affected product for a replacement and/or full refund. Also, enclosed is a response form. Please complete and return the form even if you do not have any product to return. Your Sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information (required by FDA). Thank you for your support. We are committed to re-releasing the wipeable ReTurn belt as soon as we believe that it meets the quality standards that you expect from Handicare. Please contact our Customer Experience team at 1-866-276-5438 if you have any questions regarding the recall or would like assistance with the recall. We regret any inconvenience that this action may cause, but we appreciate your understanding as we take action to ensure patient and customer satisfaction.
- Quantity
- 64
- Distribution
- US Distribution to the states of : FL, CA, NJ, NC and MD.
- Lot, serial or model codes
- All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKX
- Firm FEI
- 3007802293
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28