“DeRoyal Security Cuffs Recall: Weak Buckle May Not Hold Patient.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65740-deroyal-security-cuffs-recall-weak-buckle-may-not-hold-patient. Based on FDA recall #Z-1604-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1604-2020%22&limit=1).
The FDA announced on Feb. 27, 2020, that DeRoyal Industries Inc is recalling patient restraint SECURITY CUFFS because a buckle may not meet mechanical hold force requirements. Owners should contact the company for a remedy.
How to tell if you have it
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138
UPC: 00749756946865
Lot Code: 50192186
The hazard
One lot of the product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Context
GovInfoNow's records show DeRoyal Industries Inc has had 29 other recalls on record since June 7, 2017. Other recent recalls of similar products include Stryker Color Cuff 18"/24" Quick Connect Dual Port Cuffs (March 12, 2026), Merit Medical Allwell Angioplasty Pack (Dec. 4, 2025) and Philips Azurion System (March 31, 2026).
How to tell if you have this one
Check for the lot code 50192186 on the product label. The product is a security cuff used for patient restraint with model reference M8138.
Brand
DeRoyal
Product
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot code 50192186 on the security cuff label.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “VA, CA, FL, AZ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Virginia.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1604-2020 (February 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1604-2020 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.