FDA Medical devices recall ·
DeRoyal C-SECTION TRACEPACK recall
- Recall number
- Z-0306-2025
- Date
- (initiated October 3, 2024)
- Company / brand
- DeRoyal Industries Inc
200 Debusk Ln, Powell, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 780 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/ DI 00749756927864 (each), 50749756927869 (case): Lot Numbers: 59098305, exp 4/1/2027; 59161271, exp 3/1/2025; 59245221, exp 6/1/2025; 59287659, exp 5/1/2025; 59716337, exp 5/1/2025;59866546, exp 12/1/2025; 59962811, exp 11/1/2025; 59996754, exp 12/1/2025; 60104426, exp 11/1/2025
Distribution
US Nationwide distribution in the state of OH.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0306-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.