DeRoyal M8136Recalls & reported problems
Deroyal Industries, Inc. · SECURITY CUFFS · Class 1
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 15, 2022Terminated
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Z-1562-2022 · Root cause: Under Investigation by firm · FDA record ↗
Other Restraint, protective devices
- DeRoyal M8138Deroyal Industries, Inc. · Restraint, protective1 recall1 report
- DeRoyal M8137Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8125Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8124Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- POSEY 2532Posey Products, LLC · Restraint, Protective36 reports
- POSEY 2551Posey Products, LLC · Restraint, Protective14 reports
- POSEY 2799Posey Products, LLC · Restraint, Protective9 reports
- POSEY 2798Posey Products, LLC · Restraint, Protective7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.