Olympus Choledoscope Recalled for Lack of Clearance and Breakage
Olympus is recalling CHF-CB30S choledoscopes because they lack FDA clearance and have experienced breakage and metal protrusion during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Severe because the device is associated with breakage and protrusion of metal parts during surgical procedures, which poses a significant injury risk.
Plain-English summary
Olympus Corporation of the Americas is recalling the CHF-CB30S Choledoscope. The device was designed for endoscopic diagnosis and treatment within the biliary tract, including the common bile duct, cystic duct, and hepatic duct. The recall involves 193 devices distributed in the United States and 548 devices distributed globally.
The recall was initiated because the device did not have a 510(k) clearance from the FDA. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts. There have also been reports of breakage and displacement of the rubber on the bending section during surgical procedures.
The devices were distributed nationwide in the United States to the states of AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM, NJ, NY, OR, SC, TN, WA, and WI, as well as internationally to Japan. All lot codes are affected. Healthcare providers should stop using the device and contact Olympus for instructions on return or replacement.
The recalled product
- Product
- Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile…
- Manufacturer
- Olympus Corporation of the Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes..
Distribution
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