Class II U.S. Food and Drug Administration

Becton Dickinson & Co. BD Phoenix M50 Instrument recall: Product service credentials used by some BD technical support teams to access

Recall published 12 months ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0239-2026
Published
October 29, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Becton Dickinson & Co.
Product type
Medical devices
Units affected
4,283 units
Distribution
Nationwide
Made in
United States
Lot / code info
Catalog Number (Serial Numbers): 443624, UDI/DI: 00382904436247, (PF4176, PF4182, PF2302, PF4198, PF4149, PF4189, PF4202, PF2699, PF4200, PF4207, PF4209, PF2640, PF2769, PF3383, PF2742, PF4215, PF4204, PF0571, PF4188, PF4216, PF1642, PF4231, PF0929, PF4240, PF3443, PF0934, PF4232, PF4212, PF0566, PF3126, PF5436, PF5384, PF5396, PF5398, PF5404, PF3345, PF5443, PF3203, 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, PF5359, PF5227, PF5351, PF5365, PF5218, PF5361, PF5389, PF5265, PF5266, PF5328, PF5337, 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, PF4295, PF4337, PF4100, PF4415, PF4420, PF1054, PF4346, PF5633, PF4278, PF4439, PF5874, PF5877, PF4436, PF4430, PF5887, PF5011, PF5024, PF5048, PF5790, PF1478, PF1483, PF5047, PF4406, PF5134, PF1932, PF5021, PF5947, PF5029, PF5050, PF5130, PF5142, PF5145, PF5156, PF4412, PF1481, PF1091, PF5125, PF1096, PF5129, PF1099, PF5135, PF5088, PF1154, PF5108, PF1305, PF5164, PF6098, PF5111, PF1298, PF1373, PF1387, PF5153, PF6304, PF1477, PF6305, PF1513, PF6307, PF1743, PF5058, PF5064, PF5087, PF5078, PF0575, PF0534, PF0828, PF0928, PF5013, PF0672, PF0673, PF0675, PF1969, PF0429, PF1497, PF0533, PF2269, PF0633, PF5051, PF0841, PF1011, PF0719, PF0721, PF0737, PF0758, PF5107, PF5275, PF5493, PF5518, PF5163, PF0306, PF5472, PF0409, PF5494, PF5508, PF5509, PF5517, PF5521, PF0463, PF5522, PF5527, PF2299, PF1124, PF0468, PF2407, PF0515, PF0628, PF0630, PF5582, PF0626, PF0879, PF0677, PF1112, PF5257, PF0541, PF0794, PF1122, PF1119, PF5548, PF1001, PF5555, PF0984, PF5561, PF5571, PF5572, PF5575, PF5589, PF5591, PF2200, PF5594, PF2202, PF5598, PF2096, PF5599, PF0004, PF1569, PF1045, PF1662, PF1405, PF1641, PF1412, PF1414, PF2003, PF2132, PF2223, PF2324, PF1528, PF1147, PF2369, PF2653, PF2561, PF5608, PF5611, PF2697, PF1153, PF2546, PF0197, PF0199, PF0268, PF5733, PF0493, PF0494, PF0496, PF5957, PF1196, PF5966, PF1189, PF1195, PF1188, PF1192, PF0082, PF1202, PF0085, PF1201, PF1207, PF1206, PF1214, PF1191, PF1229, PF1230, PF1231, PF0614, PF0275, PF0190, PF0273, PF1257, PF1262, PF1063, PF1062, PF2379, PF0792, PF1208, PF0938, PF0942, PF1376, PF1384, PF1386, PF1390, PF0097, PF0094, PF0096, PF1408, PF0165, PF1285, PF0214, PF2360, PF2068, PF0307, PF2393, PF4056, PF2406, PF4017, PF3368, PF3197, PF3059, PF1354, PF1410, PF2564, PF1425, PF5173, PF5254, PF3412, PF4238, PF1430, PF1432, PF4384, PF1434, PF4223, PF4222, PF1417, PF0612, PF1422, PF1396, PF5832, PF0065, PF5833, PF0071, PF5862, PF5869, PF5822, PF0264, PF5825, PF1507, PF5829, PF1423, PF5821, PF1427, PF5818, PF5830, PF5860, PF5861, PF1452, PF1437, PF0232, PF5693, PF1436, PF5682, PF2480, PF1508, PF1517, PF0751, PF1566, PF1720, PF6189, PF6171, PF6243, PF6254, PF6175, PF1582, PF2306, PF0319, PF0322, PF4325, PF1626, PF1627, PF1752, PF1748, PF0917, PF1527, PF1531, PF0318, PF1816, PF0892, PF1537, PF1309, PF1539, PF0205, PF1371, PF1450, PF1451, PF1791, PF2236, PF2130, PF0013, PF2374, PF0023, PF0025, PF0028, PF0038, PF1591, PF1951, PF0034, PF1607, PF2752, PF1603, PF2760, PF0049, PF0054, PF4195, PF1630, PF1631, PF2975, PF3253, PF4068, PF5302, PF5320, PF0105, PF0102, PF1634, PF1637, PF1644, PF1648, PF1654, PF0600, PF1651, PF2330, PF2355, PF1669, PF2357, PF1673, PF1676, PF4367, PF2521, PF2836, PF2840, PF0144, PF580…
UPC codes
00382904436247

Products covered by this recall

BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00382904436247

Model or item number

On the rating label, the box or the instruction sheet.

  • 443624

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Becton Dickinson & Co. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Becton Dickinson & Co. — 7 Loveton Cir, Sparks, MD, 21152-9212

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Becton Dickinson & Co. medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00382904436247; model number 443624. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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