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RecallWatchMedical Device Safety
Class IIOngoingZ-0237-2026

Becton Dickinson & Co. recalls BD BACTEC Blood Culture System

Becton Dickinson & Co.Sparks, MD, United StatesReported Oct 29, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number:44557008
    Catalog # Number
    400 affected lots
    44557000382904455705UB3416UB3975UB3871AUB3753UB4823DB2572
    +392 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

What the firm is doing

Beckton, Dickenson and Company notified consignees on about 09/23/2025 via mailed letter and email. This updated letter serves as a supplement to the original field action communication, dated 10/31/2024. It is intended to clarify that the previously described issue remains unchanged; however, the scope of the impacted product SKUs has been expanded. The update specifically documents additional SKUs including refurbished product codes that were not included in the original communication. Consignees were instructed to follow outlined best practices for maintaining strong security measures to protect hospital networks and medical devices, read and understand the recall notification, provide the letter to all applicable personnel or customers if further distributed, and complete and return the Customer Response Form.

DistributionShow details

Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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