[Recalled] DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 — DeRoyal is recalling certain lots of surgical procedure pack products that cont… | FDA 2024-10-03

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 is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.

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.