Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1210-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

Colonoscope, Model Number PCF-H190DL.

Product Classification:

Class II

Date Initiated: January 11, 2024
Date Posted: March 6, 2024
Recall Number: Z-1210-2024
Event ID: 93832
Reason for Recall:

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Status: Ongoing
Product Quantity: 47
Code Information:

Model Number: PCF-H190DL; UDI DI: 04953170363672; Serial Number: 2046148, 2046377, 2500549, 2501714, 2602501, 2602549, 2602675, 2602884, 2603086, 2605185, 2605189, 2605279, 2605338, 2605343, 2615621, 2716237, 2716306, 2716379, 2727123, 2727529, 2737897, 2738603, 2839269, 2839284, 2839580, 2840038, 2840130, 2840639, 2840669, 2840719, 2840798, 2840928, 2842302, 2942674, 2942814, 2943131, 2943193, 2943240, 2943296, 2943451, 2943708, 2943820, 2944426, 2944690, 2944765, 2944939, 2945260;

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated