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BD MAX System, for in vitro diagnostic (IVD) use, labeled… recallZ-0238-2026 · Becton Dickinson & Co. · initiated Sep 23, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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.

FDA root cause category: Software design

What the company 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.

Recall details

Recall number
Z-0238-2026
Status
Open, Classified
Initiated by the company
Sep 23, 2025
Posted by the FDA
Oct 23, 2025
Recalling firm
Becton Dickinson & Co.
Quantity
62 units
Product code
OZN
FDA submissions
K111860, K120138, K130470
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.

Product description

BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.

Code information (models, lots, serial numbers)

Catalog 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).

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K111860, K120138, K130470 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97479).

Sources and updates

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