BD BACTEC™ 9240, Remanufactured 445569Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ 9240, Remanufactured · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
5 other recalls cover devices cleared under the same FDA submission (K915796); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Sep 23, 2025Class IIOpen, Classified
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.
Z-0236-2026 · Root cause: Software design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K915796. One submission often covers many models, so check the product and lot details in each record.
- Z-0596-2025 · Oct 31, 2024 · Open, ClassifiedBACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
- Z-0593-2025 · Oct 31, 2024 · Open, ClassifiedBD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
- Z-0594-2025 · Oct 31, 2024 · Open, ClassifiedBD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
- Z-0869-2014 · Dec 9, 2013 · TerminatedBD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic
- Z-0870-2014 · Dec 9, 2013 · TerminatedBD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of
Other SYSTEM, BLOOD CULTURING devices
- BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1,472 reports
- BD BACTEC™ Plus Aerobic/F Culture Vials 442023Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 deaths1,063 reports
- BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials 442021Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1 death791 reports
- BD BACTEC™ FX Top 441385Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 recalls1 death475 reports
- BD BACTEC™ Peds Plus™/F Culture Vials 442020Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING355 reports
- BD BACTEC™ Plus Anaerobic/F Culture Vials 442022Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING237 reports
- BD BACTEC™ MGIT™ 960 Instrument 445870Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING186 reports
- BACT/ALERT® FA PLUSBiomerieux , Inc. · System, blood culturing1 recall126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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