Becton Dickinson & Co.: FDA recalls

FDA enforcement reports name Becton Dickinson & Co. as the recalling firm in 77 events. The events have 185 product records. The recalls started from 2012 to 2026. All the events are device recalls.

See the 77 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

77 events, newest first.

FDA enforcement events of Becton Dickinson & Co.
Initiated	Product (first record)	Type	Class	Records	Status
7 Apr 2026	BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use	Device	Class II	2	Ongoing
23 Oct 2025	BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;	Device	Class II	1	Ongoing
23 Sep 2025	BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.	Device	Class II	6	Ongoing
23 Jun 2025	BD COR System Software. Model Number: 444829.	Device	Class II	1	Ongoing
20 May 2025	BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).	Device	Class II	1	Ongoing
12 Feb 2025	BD BBL TB Stain Kit K, Catalog (REF): 212522	Device	Class II	1	Ongoing
19 Dec 2024	BD PCR Cartridges used with MAX System. Model Number: 437519	Device	Class II	1	Ongoing
6 Nov 2024	BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263	Device	Class II	1	Ongoing
31 Oct 2024	BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007	Device	Class II	13	Ongoing
12 Sep 2024	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150	Device	Class II	1	Ongoing
1 Aug 2024	BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624	Device	Class II	2	Ongoing
18 Jul 2024	BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128	Device	Class II	1	Ongoing
9 Jul 2024	BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;	Device	Class II	1	Ongoing
7 May 2024	BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.	Device	Class II	1	Ongoing
29 Feb 2024	BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and…	Device	Class II	2	Ongoing
8 Jan 2024	Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629. These discs are used for semi-quantitative in vitro susceptibility testing	Device	Class II	30	Ongoing
12 Sep 2023	BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023	Device	Class II	1	Ongoing
8 Jun 2023	BD Synapsys Informatics Solution, Catalog Number 444150	Device	Class II	1	Ongoing
1 May 2023	BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088	Device	Class II	1	Ongoing
22 Mar 2023	BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213	Device	Class II	1	Ongoing
21 Nov 2022	BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267	Device	Class II	1	Ongoing
13 Oct 2022	BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607	Device	Class II	1	Ongoing
9 Mar 2022	BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10	Device	Class II	1	Terminated
5 Jan 2022	BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066	Device	Class II	1	Ongoing
24 Mar 2021	BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213	Device	Class II	1	Terminated
17 Mar 2021	BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558	Device	Class II	2	Terminated
7 Jan 2021	BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal…	Device	Class II	1	Terminated
8 Dec 2020	BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448605 (Discontinued)	Device	Class II	8	Terminated
20 Jul 2020	BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal…	Device	Class II	1	Terminated
14 Apr 2020	BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.	Device	Class II	3	Terminated
26 Jul 2019	BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202	Device	Class II	2	Terminated
17 Jul 2019	Kit BD Max Check-Points CPO IVD EU; Catalog # 278102	Device	Class II	19	Terminated
3 Apr 2019	BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066	Device	Class II	2	Terminated
21 Feb 2019	BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient…	Device	Class II	1	Terminated
14 Jan 2019	BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.	Device	Class II	1	Terminated
20 Dec 2018	Phoenix AST-s Indicator, Catalog Number 246009	Device	Class II	3	Terminated
22 Oct 2018	BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)	Device	Class II	1	Terminated
24 Sep 2018	BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX…	Device	Class II	2	Terminated
21 Sep 2018	BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and…	Device	Class III	1	Terminated
21 Jun 2018	BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.	Device	Class II	1	Terminated
2 Mar 2018	BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829	Device	Class III	2	Terminated
3 Oct 2017	Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.	Device	Class II	1	Terminated
18 Jul 2017	BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.	Device	Class II	3	Terminated
1 Jun 2017	BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD…	Device	Class III	1	Terminated
22 May 2017	TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.	Device	Class II	1	Terminated
11 May 2017	BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to…	Device	Class II	1	Terminated
1 Jun 2016	PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.	Device	Class III	2	Terminated
28 Mar 2016	Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization…	Device	Class II	1	Terminated
12 Feb 2016	BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial…	Device	Class II	1	Terminated
27 Aug 2015	BD AffirM VPIII Microbial Identification Test	Device	Class II	1	Terminated
29 Jun 2015	Vancomycin Screen Agar	Device	Class II	2	Terminated
27 Mar 2015	BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) – I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an…	Device	Class III	1	Terminated
21 Nov 2014	BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages…	Device	Class II	2	Terminated
7 Nov 2014	BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.	Device	Class II	1	Terminated
25 Aug 2014	EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data…	Device	Class II	1	Terminated
28 Jul 2014	BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.	Device	Class II	1	Terminated
23 Jul 2014	The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.	Device	Class II	1	Terminated
6 Jun 2014	TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and…	Device	Class II	3	Terminated
21 May 2014	BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative…	Device	Class III	1	Terminated
9 Dec 2013	BD 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 Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in…	Device	Class II	2	Terminated
11 Oct 2013	BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as *GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5* The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C.…	Device	Class II	1	Terminated
9 Sep 2013	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria…	Device	Class II	1	Terminated
8 Jul 2013	PrepStain AG. For use in the screening and detection of cervical cancer.	Device	Class II	3	Terminated
13 Jun 2013	BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part *Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds* The Affirm VPIII Microbial Identification Test is a DNA…	Device	Class II	1	Terminated
6 Jun 2013	BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part *Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds* Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this…	Device	Class II	8	Terminated
31 May 2013	BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.	Device	Class III	1	Terminated
12 Apr 2013	BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.	Device	Class II	2	Terminated
11 Mar 2013	BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.	Device	Class II	3	Terminated
8 Feb 2013	BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part *BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 For use with the BD Viper System ** Becton, Dickinson and Company 7 Loveton Circle, Sparks,…	Device	Class II	1	Terminated
13 Dec 2012	Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the…	Device	Class II	1	Terminated
11 Dec 2012	BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:*BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5*BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures.…	Device	Class II	1	Terminated
10 Dec 2012	BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part *Becton Dickinson and Company, Sparks, MD 21152 USA* Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to…	Device	Class II	1	Terminated
6 Nov 2012	BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.	Device	Class II	1	Terminated
22 Oct 2012	BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part *Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds*	Device	Class II	1	Terminated
18 Sep 2012	Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.	Device	Class II	1	Terminated
22 May 2012	BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part*GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5* BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA)…	Device	Class II	5	Terminated
12 Apr 2012	BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.	Device	Class II	2	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Becton Dickinson & Co.: events for each product type
Type		Events
Device		77

Becton Dickinson & Co.: events in each class
Class		Events
Class II		70
Class III		7

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 23

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Becton Dickinson & Co., by the year that the recall started. The largest year is 2013, with 10 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Becton Dickinson & Co.: FDA recalls. https://recallregister.com/firm/becton-dickinson-co/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MD

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Becton Dickinson & Co. have?: Class II: 70 events. Class III: 7 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Becton Dickinson & Co.?: FDA event 98657, which the firm started on 7 Apr 2026. The first product in the record is: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
How many FDA recalls of Becton Dickinson & Co. have the status Ongoing?: 23 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.