Z-1481-2024Class II

Hemostasis Probe, Model: CD-B622LA

Name: Z-1481-2024 Hemostasis Probe, Model: CD-B622LA
Creator: Olympus Corporation of the Americas
Published: 2024-01-05
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-01-05 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Hemostasis Probe, Model: CD-B622LA on 2024-01-05. FDA classified it as Class II and gives the reason as "The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1481-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-05
Posted: 2024-04-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: Hemostasis Probe, Model: CD-B622LA
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On January 30, 2024, the firm notified its only customer of the issue via URGENT: MEDICAL DEVICE FIELD REMOVAL ACTION letters. Actions to be taken by the end user: 1. Inspect your inventory and identify any products of the model and lot subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lot. 2. Please contact your Regional Customer Service, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number "XXXX and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including mispackaging, to your Regional Complaint Intake Contact. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact your regional contact person.
Quantity in commerce: 36 units (all OUS)
Distribution: International distribution only.
Product codes and lots: Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1481-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1481-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-05

Product code KNS

K123319Class IIGyrus Acmi Bicoag Hemostasis ProbeOlympus Surgical Technologies America / cleared 2012-12-14

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)