Browse Device Recalls

1,361 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,361 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 1,361 FDA device recalls in NY.

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DateProductReasonClassFirm
Jan 30, 2024 MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutan... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percuta... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the per... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percuta... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percuta... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutane... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG ... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutane... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutane... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 30, 2024 MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutan... Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... Class II Angiodynamics, Inc.
Jan 26, 2024 VITROS XT 3400 Chemistry System, Catalog No. 6844458 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS XT 7600 Integrated System, Catalog No. 6844461 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS XT 3400 Chemistry System, Catalog No. 6844458 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS XT 7600 Integrated System, Catalog No. 6844461 A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 26, 2024 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... Class II Ortho-Clinical Diagnostics, Inc.
Jan 24, 2024 ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd... Class II Siemens Healthcare Diagnostics, Inc.
Jan 24, 2024 Atellica IM Erythropoietin (EPO) Assay (100 Test) Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd... Class II Siemens Healthcare Diagnostics, Inc.
Jan 22, 2024 VITROS 3600 Immunodiagnostic System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... Class II Ortho-Clinical Diagnostics, Inc.
Jan 22, 2024 VITROS XT7600 Integrated System Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... Class II Ortho-Clinical Diagnostics, Inc.
Jan 22, 2024 VITROS 5600 Integrated System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... Class II Ortho-Clinical Diagnostics, Inc.
Dec 21, 2023 Article No. NA6050411, Valiant PhD No. 1 Econo Affected product may not perform as expected; the amalgam powder may not triturate correctly and ... Class II Ivoclar Vivadent, Inc.
Dec 18, 2023 PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H78... Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak du... Class II Angiodynamics, Inc.
Dec 15, 2023 Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Potential for a negative bias with quality control (QC) and patient sample results when using the... Class II Siemens Healthcare Diagnostics, Inc.
Nov 30, 2023 Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 30, 2023 Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 30, 2023 Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 27, 2023 VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog ... Affected lots may experience increased calibration failures or an increase in falsely elevated re... Class II Ortho-Clinical Diagnostics, Inc.
Nov 21, 2023 QMS Tacrolimus Calibrators, Product code 10015573 Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry dat... Class II Ortho-Clinical Diagnostics, Inc.
Oct 25, 2023 VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITR... Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coa... Class II Ortho-Clinical Diagnostics, INc.
Oct 10, 2023 VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Prod... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Co... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS XT 7600 Integrated System Product Code 6844461 Running Software Versio... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Cod... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 2, 2023 The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut... There is a potential for unexpected failure of the electrical components within the Carestream He... Class II Carestream Health, Inc.
Oct 2, 2023 DRX Revolution Mobile X-Ray System Unexpected failure of electrical components within the CPI generator. Class II Carestream Health, Inc.
Sep 12, 2023 VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 S... Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cau... Class II Ortho-Clinical Diagnostics, INc.
Aug 9, 2023 Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry Sy... Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactur... Class II Ortho-Clinical Diagnostics, Inc.
Aug 8, 2023 ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 ... There is a potential for a positive bias on Quality Control (QC) and patient sample results when ... Class II Siemens Healthcare Diagnostics, Inc.
Aug 5, 2023 VITROS XT Chemistry Products TBIL-ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... Class II Ortho-Clinical Diagnostics, INc.
Aug 5, 2023 VITROS XT Chemistry Products ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... Class II Ortho-Clinical Diagnostics, INc.
Jul 25, 2023 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 1... There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 20, 2023 PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the su... Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthal... Class II Reichert, Inc.
Jul 10, 2023 Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative det... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.

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.