Z-0238-2026Class II

BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX...

Name: Z-0238-2026 BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX...
Creator: Becton Dickinson & Co.
Published: 2025-09-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2025-09-23 / Open, Classified / root cause: software

FDA source

Becton Dickinson & Co. began a recall of BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927 on 2025-09-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0238-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-23
Posted: 2025-10-23
Recalling firm: Becton Dickinson & Co
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.
Product code: OZN C. Difficile Toxin Gene Amplification Assay
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 62 units
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 codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0238-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0236-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0237-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0238-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0239-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0240-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23

Product code OZN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)