FDAClass IIMarch 6, 2024

Colonoscope recall

Colonoscope, Model Number CF-HQ190L.

Why was Colonoscope recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: CF-HQ190L; UDI DI: 04953170305115; Serial Number: 2082724, 2082896, 2082936, 2083461, 2083765, 2084560, 2085050, 2186261, 2187110, 2187274, 2187811, 2188037, 2188206, 2200530, 2201625, 2201677, 2201844, 2202345, 2288483, 2288940, 2289129, 2289391, 2289421, 2289572, 2290978, 2291472, 2303312, 2304024, 2304070, 2314598, 2315390, 2391750, 2391772, 2391857, 2392281, 2417328, 2417450, 2417702, 2417736, 2417755, 2418202, 2418754, 2418843, 2419006, 2419007, 2419105, 2510489, 2510795, 2510801, 2511164, 2512292, 2512458, 2512470, 2512569, 2512817, 2513285, 2524619, 2524916, 2625144, 2635605, 2635832, 2636020, 2636500, 2636782, 2637892, 2659060, 2659357, 2759754, 2761671, 2762243, 2772492, 2773247, 2773259, 2773324, 2773552, 2874236, 2875490, 2875615, 2875616, 2875656, 2876636, 2876811, 2876877, 2877237, 2877319, 2877901, 2978291, 2978331, 2978640, 2979287, 2979510, 2980281, 2980304, 2980541, 2981322, 2982038, 2982143;

Product
Colonoscope, Model Number CF-HQ190L.
Recalling firm
Olympus Corporation of the Americas
Quantity
97
Distribution
US Nationwide distribution.
Recall date
March 6, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls