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Use caution Medical device recall · FDA · Published July 15, 2022

DeRoyal Limb Holders: Webbing Strap Can Slide, Not Secure

DeRoyal recalls wrist and ankle limb holders with improper webbing strap lacing that may slide, causing injury. Affected models include M8124, M8125, M8136, and M8137.

🇺🇸 FDA recall #Z-1562-2022Medical deviceDeRoyal ›
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Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703
✎ GovInfoNow plain-language explainer

What happened, in plain English

DeRoyal recalls wrist and ankle limb holders that have a webbing strap which can slide due to improper lacing through the buckle. This could lead to the holder becoming loose and potentially causing injury if used improperly. Read more at govinfonow.com/recall/60360-deroyal-limb-holders-webbing-strap-can-slide-not-secure.

Source Summary by GovInfoNow · govinfonow.com/recall/60360-deroyal-limb-holders-webbing-strap-can-slide-not-secure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1562-2022

Cite this page

“DeRoyal Limb Holders: Webbing Strap Can Slide, Not Secure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60360-deroyal-limb-holders-webbing-strap-can-slide-not-secure. Based on FDA recall #Z-1562-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1562-2022%22&limit=1).

Why it’s dangerous

The webbing strap is laced incorrectly through the buckle's teeth, allowing it to slide. This makes the strap insecure and could become loose, potentially causing injury if the holder slips during use.

Who’s affected

People who own or use DeRoyal limb holders for medical or security purposes, especially those who rely on the holders for immobilization. Those with limited mobility or who use the holders for extended periods are at higher risk.

How to tell if you have this one

Check for model numbers M8124, M8125, M8136, or M8137 on the product. These limb holders were sold with specific lot numbers and expiration dates listed in the recall notice.

  • Brand
    DeRoyal
  • Product
    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Look for model numbers M8124, M8125, M8136, or M8137 on the limb holder to confirm if it is affected.

  2. Ensure Proper Lacing

    Lace the webbing strap correctly through the buckle's teeth to prevent slippage and ensure security.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: named in the noticeRIMassachusetts: nationwideMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Indiana, Nevada, Rhode Island, Tennessee, Texas, West Virginia.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Jul 15, 202212. FDA classified it Class II: Aug 22, 202223. Published in FDA’s Enforcement Report: Aug 31, 202234. FDA terminated the recall: Aug 6, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1562-2022 (July 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1562-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA