Browse Device Recalls
64 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 64 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 64 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 8, 2026 | Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6... | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | Swan-Ganz Pacing Catheter, Models: D200F7; | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 340335 | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jun 3, 2025 | REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. ... | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jun 3, 2025 | REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cy... | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, U... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Aug 12, 2024 | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FA... | Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube a... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| 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 |
| Dec 23, 2016 | BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ... | Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n... | Class II | Becton Dickinson & Company |
| 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 |
| Jul 10, 2013 | BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length R... | The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. | Class II | Becton Dickinson & Company |
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.