BiCOAG recallZ-1481-2024 · Olympus Corporation of the Americas · initiated Jan 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1481-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 5, 2024
- Posted by the FDA
- Apr 5, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 36 units (all OUS)
- Product code
- KNS
- FDA submissions
- K123319
- Distribution
- International distribution only.
Product description
Hemostasis Probe, Model: CD-B622LA
Code information (models, lots, serial numbers)
Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BiCOAG CD-B622LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)2 recalls16 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K123319 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BiCOAG CD-B610LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)1 recall7 reports
- BiCOAG CD-B620LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)1 recall7 reports
- BiCOAG CD-B612LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)1 recall6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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