Z-0119-2021Class II

Olympus CHF-CB30S Choledoscope

Name: Z-0119-2021 Olympus CHF-CB30S Choledoscope
Creator: Olympus Corporation of the Americas
Published: 2020-08-31
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2020-08-31 / Terminated / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2020-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0119-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-10-16
Terminated: 2022-12-06
Recalling firm: OLYMPUS Corporation of the Americas
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 duct, cystic duct, and hepatic duct).
Product code: FBN Choledochoscope And Accessories, Flexible/Rigid
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: All affected customers were sent a "URGENT: MEDICAL DEVICE REMOVAL ACTION" letter on 08/31/2020 stating the following: Olympus Corporation notified direct customer accounts on 08/31/2020 via recall notification letter. Letter states reason for recall, health risk and action to take. Actions to be taken by customers including the following: 1. Inspect your inventory and identify any CHF-CB30S devices. 2. Cease any further use of any CHF-CB30S device you have, remove it from your inventory and quarantine it until it is shipped back to us. 3. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization for you to return any CHF-CB30S at no charge. 4. Olympus will reimburse you for each returned CHF-CB30S. Please contact our customer Service representative as indicated in step 3 for the reimbursement amount for your CHF-CB30S choledoschope. 5. Access the Olympus recall portal to indicate that you have received this notification. go to https://olympusamerica.com/recall. Enter the recall number Recall-0365 and provide your contact information as indicated in the portal. 6. If you may have further distributed the CHF-CB30S, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter. OMSC requests you to report any patient injuries associated with any OMSC endoscope. Call our Technical Assistance Center (TAC) at 1-800-848-9024, option 1 to report complaints. If you have any questions or concerns, please do not hesitate to contact me directly at 484-896-5688 or at [email protected].
Quantity in commerce: 193 devices distributed in the U.S. 548 devices distributed globally.
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.
Product codes and lots: All lot codes..

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-16

Product code FBN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)