DeRoyal recalls security cuffs with a weak buckle that may not hold patients securely. Affected units have lot code 50192186. Contact for remedy.
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
DeRoyal is recalling security cuffs that were made with a buckle that doesn't hold securely. This could lead to patients not being restrained properly, which is a safety risk.
The buckle in some units doesn't meet the required strength to hold patients securely. This could cause the cuff to slip off during use, potentially leading to patient injury.
Healthcare workers who use these cuffs for patient restraint are most at risk. The recall affects specific units sold with lot code 50192186.
Check for the lot code 50192186 on the product label. The product is a security cuff used for patient restraint with model reference M8138.
Look for the lot code 50192186 on the security cuff label.
The recall is because one lot of product was made with a buckle that doesn't meet the required strength for patient restraint.
Check the product label for lot code 50192186. The product is a security cuff used for patient restraint with model reference M8138.
The recall record does not specify a remedy, so contact DeRoyal for further instructions.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1604-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1604-2020 from DeRoyal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
