DeRoyal M8124Recalls & reported problems
Deroyal Industries, Inc. · Limb Holder, Wrist · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Other Restraint, protective devices
- DeRoyal M8138Deroyal Industries, Inc. · Restraint, protective1 recall1 report
- DeRoyal M8125Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8137Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8136Deroyal 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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