Class II U.S. Food and Drug Administration

Becton Dickinson & Co. BD Bactec Blood Culture System 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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-0236-2026
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
177 units
Distribution
Nationwide
Made in
United States
Lot / code info
1. Catalog Number: 44138509; UDI/DI: 00382904413859; Serial Numbers: FT5675, FT5497, FT4948, FT5781, FT5120, FT3993, FT7779, FT3387, FT1993, FT5019, FT9109, FT8412, FT7176, FT7344, FT4282, FT7400, FT6093, FT0962, FT2780, FT0795, FT0794, FT2799, FT5924, FT5279, FT5286, FT0572, FT4931, FT7289, FT9801, FT2652, FT5232, FT1348, FT8083, FT0640, FT7159, FT7034, FT8410, FT0098, FT2650, FT6203, FT3480, FT4917, FT3031, FT3033, FT4902, FT7189. 2. Catalog Number: 441676; UDI/DI: 00382904416768; Serial Numbers: FT7439A, FT7201A, FT5679, FT0599, FT0598, FT0644, FT0600, FT5025, FT2845, FT0525, FT0715, FT4439, FT0330, FT2313, FT3020, FT3022, FT0745, FT5090, FT4340, FT6225, FT4977, FT0571, FT0570, FT0498, FT5248, FT5270, FT3537, FT4448, FT3538, FT3486, FT0340, FT1517, FT5590, FT3030, FT4800, FT1774, FT2263, FT5014, FT5013, FT7184A. 3. Catalog Number: 445569; UDI/DI: 00382904455699; Serial Numbers: DB4372, DB6043, DB5030, DB5825, DB2835, DB3251, DB3245, DB3145, DB5876, DB5906, DB3143, DB3204, DB6891, PM4385R, DB4718, DB3231, DB2786, DB6628, DB6393, DB6936, DB4987, DB5347A, DB6123, DB6281, DB6933, DB6451, DB5602, DB5858, DB4763, DB6302, DB6165, DB5596, DB5089, DB7157, DB5021, DB3086, DB4776, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, RC1164, DB6323, DB4550, DB6213, DB5083, DB6383, DB6381, DB6457, DB6169, DB6212, DB6929, DB6978, DB6913, DB6540, DB6699, DB6989. 4. Catalog Number: 44229609; UDI/DI: 00382904422967; Serial Numbers: FF1979, FF0713, FF0410, FF1561, FF2832, FF4395, FF1500, FF0697, FF0933, FF1499, FF1025, FF5511, FF0027, FF1118, FF3195, FF0115, FF5979, FF6535, FF0391, FF3284, FF0772, FF0570, FF0638, FF1599, FF1271.
UPC codes
00382904413859, 00382904416768, 00382904455699, 00382904422967

Products covered by this recall

BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.

Check your product

The notice names 27 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.

  • 00382904413859
  • 00382904416768
  • 00382904455699
  • 00382904422967

Model or item number

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

  • 441676
  • 445569
  • 44229609

Serial number

On the rating plate, often next to the date of manufacture.

  • FT5675
  • FT5497
  • FT4948
  • FT5781
  • FT5120
  • FT7439A
  • FT7201A
  • FT5679
  • FT0599
  • FT0598
  • DB4372
  • DB6043
  • DB5030
  • DB5825
  • DB2835
  • FF1979
  • FF0713
  • FF0410
  • FF1561
  • FF2832

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. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 00382904413859, 00382904416768, 00382904455699; model number 441676, 445569, 44229609. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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