Z-0906-2023 Class II Terminated
FDA device recall Z-0906-2023 was initiated by DeRoyal Industries Inc on Nov 28, 2022 and is designated Class II. Reason for recall: DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the… The recall status is terminated (terminated Mar 18, 2026). Affected quantity: 320 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 28, 2022
- Termination Date
- Mar 18, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320 units
Product Description
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Reason for Recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.
Distribution Pattern
Distribution in US states of VA, and SC.
Code Information
GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0906-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026