DeRoyal recalls PEDI ORTHO PACKs with specific lot numbers due to potential injury from affected Steri Drapes. Affected units contain 3M Health Care Steri Drapes.
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
DeRoyal is recalling PEDI ORTHO PACKs that include 3M Health Care Steri Drapes with specific lot numbers. This recall is due to a risk of injury from the drapes.
The recall involves 3M Health Care Steri Drapes that may pose a risk of injury. However, the specific hazard mechanism is not clearly described in the recall notice.
Patients and caregivers using the DeRoyal PEDI ORTHO PACKs with the affected lot numbers are most at risk. The recall applies to specific units sold with the listed lot numbers.
Check the lot number on the DeRoyal PEDI ORTHO PACK, which is Lot 56181816 expiring 10/1/2023. The affected product is identified by the reference number 89-5323.20.
Look for the lot number on the DeRoyal PEDI ORTHO PACK, which should be Lot 56181816 expiring 10/1/2023.
DeRoyal PEDI ORTHO PACK with reference number 89-5323.20 and lot number 56181816 expiring 10/1/2023.
The recall is due to a risk of injury from the 3M Health Care Steri Drapes included in the product.
The recall notice does not specify a remedy, so no action is required beyond checking the lot number.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0565-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0565-2023 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.
