Olympus recalls CHF-CB30S choledoscope due to potential metal breakage and rubber displacement during surgery. Affected units lack 510(k) clearance and may cause injury.
The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.
Olymp: Olympus CHF-CB30S choledoscopes are recalled because they lack 510(k) clearance and have been linked to metal breakage and rubber displacement during surgery. This could lead to injury if used improperly.
The choledoscope lacks proper regulatory clearance and has been associated with metal parts breaking and protruding, as well as rubber sections breaking and shifting during surgery. This could cause injury to patients or the surgical team.
Surgical teams using the Olympus CHF-CB30S choledoscope for biliary tract procedures are most at risk. The device is used in specific medical settings with endoscopic equipment.
The Olympus CHF-CB30S choledoscope is used with Olympus TV camera systems for biliary tract procedures. All units are affected, but the exact lot codes are not specified in the recall.
Look for the model number on the device or packaging to confirm it's a CHF-CB30S choledoscope.
The recall states the device lacks 510(k) clearance and has been associated with breakage and displacement during surgery, so it is not safe to use as recalled.
The recall does not specify a remedy, so the official notice does not provide instructions for action.
The device lacks 510(k) clearance and has been linked to metal breakage and rubber displacement during surgical procedures.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0119-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0119-2021 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
