Z-1814-2022 Class II Ongoing
FDA device recall Z-1814-2022 was initiated by Olympus Corporation Of The Americas on Aug 12, 2022 and is designated Class II. Reason for recall: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment The recall status is ongoing. Affected quantity: 231.4 units (5/box); 510 units (5/box) OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- Aug 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 231.4 units (5/box); 510 units (5/box) OUS
Product Description
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Reason for Recall
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Distribution Pattern
Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Code Information
UDI-DI: 00821925044555 Lot Numbers: CA191233 CA191234 CA191235 CA233514 CA233515 CA233516 CA233517 CA233518 CA236206 CA236208 CA236213 CA236215 CA236216 CA236217 CA236220 CA236227 CA236228 CA236230 CA236238 CA236240 CA236243 CA236261 CA236272 CA236273 CA236276 CA236278 CA236290
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1814-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026