is it on recall

Recall archive / FDA device enforcement

BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Cata... — FDA record Z-0238-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 23, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Reason
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.
Classification
Class II
Recalling firm
Becton Dickinson & Co.
Quantity
62 units
Agency-reported status
Ongoing
Source record identifier
Z-0238-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityCatalog Number (Serial Numbers): 44191609, UDI/DI: 00382904419165, (CT0883, CT0636, CT0462, CT0303, CT1217, CT0257, CT0709, CT0786, CT0713, CT0765, CT0668, CT0930, CT0181, CT0564, CM0113, CM0126, CT1319, CT0634, CT1176, CT0910, CM0066, CT0540, CT0138, CM0072, CM0087, CT0534, CT0278, CM0047, CT2365, CT0242, CM0042, CT0558, CT0648, CT0723, CT0855, CT1179, CT0446, CM0125, CT0873, CT0875, CT1369, CM0009, CT0336, CT0879, CT1354, CT0309, CT0739, CT1767, CT1551, CT1320, CT1351), 441927, UDI/DI: 00382904419271, (CR1423A, CR0005, CR0009, CR0003, CT0592, CR0008, CR0941, CR0007, CM0105, CR0705, CR0589).

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Oct 29, 2025
Recall initiation date
Sep 23, 2025
Center classification date
Oct 23, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records

Medical devices recordsBecton Dickinson & Co. records