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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Olympus Corporation of the Americas: 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

Agency Publication Date: September 26, 2022
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Affected Products

Product: Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170

Lot Numbers:
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Product: 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.

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

Lot Numbers:
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Product: Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

UDI-DI: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90788
Status: Active
Manufacturer: Olympus Corporation of the Americas
Manufactured In: United States
Units Affected: 3 products (27 units (5/box) US; 83 units(5/box) OUS; 231.4 units (5/box); 510 units (5/box) OUS; 44 units (5/box); 133 units (5/box) OUS)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.