[Recalled] DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 — DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes w… | FDA 2022-11-03

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from DeRoyal Industries Inc

• DeRoyal MYELOGRAM PACK, REF 89-9304.05 — Class II
• DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11 — Class II
• DeRoyal VIT RD PACK 86ST, REF 89-7308.09 — Class II
• DeRoyal FOOT PACK, REF 89-9252.08 — Class II
• DeRoyal PAIN TRAY, REF 89-10464.03 — Class II
• DeRoyal SHOULDER KIT, REF 89-9497.08 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.