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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Corporation of the Americas: BICOAG Hemostasis Probe Recalled for Labeling and Connector Mismatch

Agency Publication Date: April 5, 2024
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Summary

Olympus Corporation of the Americas is recalling 36 units of the BICOAG Hemostasis Probe, Model CD-B622LA, because the product was mispackaged. Probes with a coaxial plug were placed into packages and incorrectly labeled as having a fixed pin connector. This mismatch could lead to delays in surgical procedures or incompatibility with equipment in the operating room. All affected units were distributed internationally (outside the United States).

Risk

The incorrect connector type prevents the device from being used as intended with specific surgical equipment. This error can result in a delay of treatment or an interruption during a medical procedure while a compatible replacement is sought.

What You Should Do

  1. Identify your product by checking the packaging for Hemostasis Probe Model CD-B622LA with Lot Number KR214212 and UDI/DI 00821925039452.
  2. Inspect the device to determine if the connector matches your surgical equipment requirements, as the package may incorrectly state it has a fixed pin connector when it actually contains a coaxial plug.
  3. If you have an affected probe, stop using the device and contact your healthcare provider or Olympus Corporation of the Americas for instructions on returning the product or obtaining a replacement.
  4. Contact the manufacturer, Olympus Corporation of the Americas, at their Center Valley, Pennsylvania headquarters for further assistance regarding this voluntary recall.
  5. For additional questions or to report issues, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification

How to: The firm initiated the recall via a notification letter to affected customers.

Affected Products

Product: Hemostasis Probe, Model: CD-B622LA
Model / REF:
CD-B622LA
UPC Codes:
00821925039452
Lot Numbers:
KR214212

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94150
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: international distributors
Manufactured In: United States
Units Affected: 36 units (all OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.