Browse Device Recalls
183 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 183 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 183 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 23, 2025 | BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; | The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system fro... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Aut... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: ... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX,... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), C... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 S... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD EpiCenter Microbiology Data Management System, labeled as the following: ... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Jun 23, 2025 | BD COR System Software. Model Number: 444829. | Potential for functionality issue that supports the Over labeling feature and could lead to poss... | Class II | Becton Dickinson & Co. |
| May 20, 2025 | BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility te... | BD has received additional complaints of intermittent false resistance results for PZA during sus... | Class II | Becton Dickinson & Co. |
| Feb 12, 2025 | BD BBL TB Stain Kit K, Catalog (REF): 212522 | One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate o... | Class II | Becton Dickinson & Co. |
| Dec 19, 2024 | BD PCR Cartridges used with MAX System. Model Number: 437519 | Potential for signal drift in specific lots of BD PCR Cartridges. | Class II | Becton Dickinson & Co. |
| Nov 6, 2024 | BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicil... | BD identified through potency testing as part of a stability test request to monitor Ampicillin A... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catal... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD EpiCenter Data Management System Version or Model: 440887 Catalog Number... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD EpiCenter Data Management System, Multi User Software Version or Model: 4... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: ... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Num... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 4... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Sep 12, 2024 | BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.... | Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint f... | Class II | Becton Dickinson & Co. |
| Aug 1, 2024 | BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial s... | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix"... | Class II | Becton Dickinson & Co. |
| Aug 1, 2024 | BD Phoenix M50 instrument -Intended for the rapid identification (ID) and ant... | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix"... | Class II | Becton Dickinson & Co. |
| Jul 18, 2024 | BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility te... | May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility... | Class II | Becton Dickinson & Co. |
| Jul 9, 2024 | BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solut... | There is a potential risk that the image colony count does not adequately reflect the actual plat... | Class II | Becton Dickinson & Co. |
| May 7, 2024 | BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 ... | Assays may produce false negative results due to decreased activity of the enzyme utilized in man... | Class II | Becton Dickinson & Co. |
| Feb 29, 2024 | BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix ... | Products were found to have confirmed drug cross contamination prior to release may lead to incor... | Class II | Becton Dickinson & Co. |
| Feb 29, 2024 | BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix ... | Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 i... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro ... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susce... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susc... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Ca... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susce... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro suscep... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for ... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quanti... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro su... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro su... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susce... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.