FDA Medical devices recall ·
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 recall
- Recall number
- Z-0592-2025
- Date
- (initiated October 31, 2024)
- Company / brand
- Becton Dickinson & Co.
7 Loveton Cir, Sparks, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,411 units (567 US, 3,844 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog No: 443624; UDI-DI:00382904436247; Serial Numbers: PF4176, PF4182, PF2302, PF4198, PF4149, PF4189, PF4202, PF2699, PF4200, PF4207, PF4209, PF2704, PF2640, PF2769, PF3383, PF2742, PF5292, PF4215, PF4204, PF0571, PF4188, PF4216, PF1642, PF4231, PF0929, PF4240, PF3443, PF0934, PF4232, PF4212, PF0566, PF3126, PF5408, PF5436, PF1716, PF5384, PF5396, PF5398, PF5404, PF3345, PF5443, PF3203, PF3128, PF0598, PF3447, PF0601, PF5489, PF5495, PF5022, PF5063, PF3362, PF3340, PF5459, PF5492, PF5462, PF5499, PF0703, PF5466, PF0880, PF0705, PF5525, PF5469, PF5471, PF3397, PF4309, PF4397, PF5547, PF0632, PF0638, PF4443, PF0637, PF5200, PF5549, PF5202, PF5550, PF0643, PF5049, PF0639, PF3204, PF5207, PF5094, PF5209, PF5117, PF1352, PF5217, PF5148, PF5231, PF5195, PF5097, PF5162, PF5109, PF5169, PF5179, PF5183, PF2063, PF5197, PF5203, PF5168, PF5323, PF5329, PF0687, PF5352, PF5353, PF5418, PF5350, PF2796, PF5359, PF5227, PF3169, PF5351, PF5365, PF5218, PF5361, PF5389, PF5265, PF5266, PF5328, PF5337, PF2274, PF0707, PF6126, PF0718, PF5356, PF5403, PF6167, PF5027, PF5349, PF5371, PF6174, PF4049, PF4071, PF4444, PF4064, PF4292, PF4305, PF4306, PF4315, PF4317, PF5042, PF4285, PF4287, PF4304, PF4373, PF4376, PF4407, PF4297, PF5043, PF4294, PF5072, PF5082, PF4251, PF4254, PF4393, PF4394, PF1032, PF5140, PF4252, PF5143, PF4253, PF5144, PF4335, PF4379, PF4390, PF4419, PF4308, PF5414, PF4295, PF5431, PF4337, PF4100, PF4415, PF4420, PF1054, PF2590, PF4346, PF5633, PF4278, PF4439, PF5874, PF5877, P
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.
States: Georgia Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0592-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.