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DeRoyal Industries Inc recall records

174 reported ongoing

181 records in this archive. Latest source date May 18, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuff...

The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.

Official source
FDA device enforcement

DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surg...

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Class IIReported terminated

Distribution: US distribution to Florida, New Jersey, and Tennessee

Official source
FDA device enforcement

DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Class IIReported terminated

Distribution: US distribution to Florida, New Jersey, and Tennessee

Official source

Reasons in these listed records

  • XXX
  • DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
  • Procedure packs contained a recalled product.
  • The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

These examples come from this result page and are not a ranking of every recall reason.

Checking DeRoyal Industries Inc

Is there a recall on deroyal industries inc right now?

This archive contains 181 records, including 174 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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