Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1211-2024)

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-H190L.

Product Classification:

Class II

Date Initiated: January 11, 2024

Date Posted: March 6, 2024

Recall Number: Z-1211-2024

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: 31

Code Information:

Model Number: PCF-H190L; UDI DI: 04953170305191; Serial Number: 2201678, 2201735, 2301759, 2301775, 2301929, 2301930, 2302159, 2302280, 2302281, 2302380, 2302506, 2303832, 2303927, 2404124, 2404132, 2404806, 2404888, 2404967, 2405012, 2405253, 2405290, 2405353, 2517013, 2517120, 2517422, 2517440, 2517541, 2517616, 2517649, 2517705, 2628544;

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated