Recall Z-0589-2025— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-10-31. FDA's recall record names no specific 510(k) clearance for this event. Product: BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990. Reason: BD confirmed that 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-31
- Firm location
- Sparks, MD, United States
Product description
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Reason for recall
BD confirmed that 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.