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Browse Device Recalls

35 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35 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 35 FDA device recalls.

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DateProductReasonClassFirm
May 8, 2024 BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit... Multitest with compromised raw material used to assess immune system status may result in flow cy... Class II Becton, Dickinson and Company, BD Biosciences
Oct 25, 2023 CD11b APC: ASR, REF: 340936, and CE, REF: 333143 In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluor... Class II Becton, Dickinson and Company, BD Biosciences
Oct 3, 2022 BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ... Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... Class II Becton, Dickinson and Company, BD Biosciences
Oct 3, 2022 BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ... Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... Class II Becton, Dickinson and Company, BD Biosciences
Oct 3, 2022 BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ... Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... Class II Becton, Dickinson and Company, BD Biosciences
Mar 25, 2022 BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the An... Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. Class II Becton, Dickinson and Company, BD Biosciences
Mar 25, 2022 BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Ant... Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. Class II Becton, Dickinson and Company, BD Biosciences
Jul 22, 2021 BD" Mouse IgG2a Isotype Control APC X39 ASR Complaints have been received for performance issues related to high background and staining. th... Class II Becton, Dickinson and Company, BD Biosciences
Oct 5, 2020 BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a com... Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression tha... Class II Becton, Dickinson and Company, BD Biosciences
Mar 31, 2020 Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417... False positive reaction on the reagent. Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 6591... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when u... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The ... The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... Class II Becton, Dickinson and Company, BD Biosciences
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III i... The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... Class II Becton, Dickinson and Company, BD Biosciences
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSC... The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encou... Class II Becton, Dickinson and Company, BD Biosciences
Jan 2, 2019 BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66... A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 ... Class III Becton, Dickinson and Company, BD Biosciences
May 16, 2018 BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Mode... The solenoid plunger tip length is too short resulting in insufficient engagement to the Univers... Class III Becton, Dickinson and Company, BD Biosciences
Sep 21, 2016 CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody r... CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity Class II Becton, Dickinson and Company, BD Biosciences
Jul 18, 2016 BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Th... Class III Becton, Dickinson and Company, BD Biosciences
Jun 24, 2016 BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tub... One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to a... Class II Becton, Dickinson and Company, BD Biosciences
Mar 31, 2016 BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucou... One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% differenc... Class II Becton, Dickinson and Company, BD Biosciences
Mar 18, 2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor... Class III Becton, Dickinson and Company, BD Biosciences
Jan 25, 2016 BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ... Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expi... Class III Becton, Dickinson and Company, BD Biosciences
Dec 14, 2015 FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting function... Class III Becton, Dickinson and Company, BD Biosciences
Oct 30, 2015 BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5... Three lots of CD64 (MD22) are contaminated with CD4 antibody. Class II Becton, Dickinson and Company, BD Biosciences
Sep 30, 2015 BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 a... Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. Class III Becton, Dickinson and Company, BD Biosciences
Aug 27, 2015 CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Cata... CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. Class III Becton, Dickinson and Company, BD Biosciences
Jul 17, 2015 BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 33580... Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody whi... Class II Becton, Dickinson and Company, BD Biosciences

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.