FDA recall Z-0306-2025

Product

DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

Reason for recall

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.

Distribution

US Nationwide distribution in the state of OH.

Key facts

Status

Ongoing

Initiation date

2024-10-03

Report date

2024-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2025