FDA (Devices) recall action 93832
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.
Olympus is recalling certain repaired Model CF-HQ190I colonoscopes assembled without protective adhesive, which may cause equipment failure under vibration, temperature changes, or shock.
Olympus is recalling two colonoscopes (Model CF-Q180AL, serial numbers 2602060 and 2603763) due to missing protective adhesive that normally guards against vibration, temperature changes, and shock loads.
Olympus has recalled certain repaired colonoscope models lacking protective adhesive that could fail under vibration, temperature, or severe shock loads. Affected models include the PCF-H190TL, distributed nationwide.
Olympus Corporation is recalling 18 colonoscopes with missing adhesive that protects against physical stress. The missing protective adhesive could allow device failure under vibration, temperature fluctuation, or shock.
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
Olympus Corporation recalled 31 colonoscopes lacking a protective adhesive that shields against vibration, temperature fluctuations, and shock. The missing adhesive may affect device structural integrity under physical stress.
Olympus is recalling 47 colonoscope units (Model PCF-H190DL) because they were assembled without protective adhesive. The missing adhesive may cause equipment failure under vibration, temperature changes, or shock.
Olympus Corporation is recalling 97 Colonoscope Model CF-HQ190L units distributed nationwide. The devices were assembled without protective adhesive, risking malfunction under vibration, temperature changes, or shock.
Olympus is recalling 28 colonoscopes (Model PCF-HQ190L) due to missing adhesive that protects the device from vibration, temperature changes, and physical shock. The defect could cause device malfunction during procedures.