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Becton Dickinson & Co.

Becton Dickinson & Co. Recalls

All product recalls associated with Becton Dickinson & Co..

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Recall Summary

Total Recalls

102

Past Year

13

Class I (Serious)

0

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 102 recalls

BD Kiestra Cuvette Array (Becton Dickinson) – Barcode Formatting Error (2025)

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

FDAOct 23, 2025Nationwide• Becton Dickinson & Co.

BD Luer Tip Caps (Becton Dickinson) – Biocompatibility Failure (2025)

BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

FDAOct 14, 2025Nationwide• Becton Dickinson & Company

BD Veritor Connect Software (BD) – credential breach (2025)

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.

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Moderate

FDASep 23, 2025Nationwide• Becton Dickinson & Co.

BACTEC Blood Culture System (BD) – credential breach (2025)

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.

FDASep 23, 2025Nationwide• Becton Dickinson & Co.

BD EpiCenter System (BD) – credential breach (2025)

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.

FDASep 23, 2025Nationwide• Becton Dickinson & Co.

BD Phoenix M50 Instrument (BD) – credential breach (2025)

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.

FDASep 23, 2025Nationwide• Becton Dickinson & Co.

BD MAX System (BD) – credential breach (2025)

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.

FDASep 23, 2025Nationwide• Becton Dickinson & Co.

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

FDAJul 8, 2025Nationwide• Becton, Dickinson and Company, BD Bio Sciences

BD COR System Software (Becton Dickinson) – Functionality Issue (2025)

Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

FDAJun 23, 2025Nationwide• Becton Dickinson & Co.

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

FDAJun 3, 2025AZ, AR, CA +34 more• Becton, Dickinson and Company, BD Bio Sciences

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

FDAJun 3, 2025AZ, AR, CA +34 more• Becton, Dickinson and Company, BD Bio Sciences

BD BACTEC MGIT 960 PZA Kit (Becton Dickinson) – False Test Results (2025)

BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

FDAMay 20, 2025Nationwide• Becton Dickinson & Co.

BD BBL TB Stain Kit (Becton Dickinson) – expiration mismatch (2025)

One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

FDAFeb 12, 2025AZ, CA, CO +11 more• Becton Dickinson & Co.

BD PCR Cartridges (Becton Dickinson) – Signal Drift Risk (2024)

Potential for signal drift in specific lots of BD PCR Cartridges.

FDADec 19, 2024Nationwide• Becton Dickinson & Co.

BD BBL Sensi Disc Ampicillin (Becton Dickinson) – Potency Decrease (2024)

BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility

FDANov 6, 2024Nationwide• Becton Dickinson & Co.

FACSLyric 3L8C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 2L4C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 3L12C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 3L10C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 2L6C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences