UnratedMedical device recall · FDA · Published August 31, 2020
Olympus CHF-C: Risk of metal breakage during surgery
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.
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Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610
“Olympus CHF-C: Risk of metal breakage during surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64408-olympus-chf-c-risk-of-metal-breakage-during-surgery. Based on FDA recall #Z-0119-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0119-2021%22&limit=1).
The FDA announced on 2020-08-31 that Olympus Corporation of the Americas is recalling the CHF-CB30S Choledoscope because it lacked required 510(k) clearance. The device has also been associated with breakage and metal protrusion during use.
How to tell if you have it
Brand: Olympus
Product: CHF-CB30S Choledoscope
The hazard
The FDA stated the 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.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (2026-08-27), the Olympus M3 Gold Autoclavable Lateral Telescope (2026-08-24), and the Olympus BiCOAG Hemostasis Probe (2026-08-19). Other recent recalls of similar products include Medline Recalls Bronchoscopic Kits with Olympus Biopsy Valves (2026-02-16) and Medline convenience kits with Olympus biopsy valves (2026-02-16).
How to tell if you have this one
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.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for the model number on the device or packaging to confirm it's a CHF-CB30S choledoscope.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in states of: AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM, NJ, NY, OR, SC, TN, WA, and WI; and International to: Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Florida, Georgia, Illinois, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, North Carolina, Oregon, South Carolina, Tennessee, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0119-2021 (August 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0119-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.