Browse Device Recalls

1,382 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,382 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 1,382 FDA device recalls in NY.

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DateProductReasonClassFirm
Mar 18, 2024 DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in a... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in ... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use ... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H78710302... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 13, 2024 Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human ... Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica C... Class II Siemens Healthcare Diagnostics, Inc.
Mar 1, 2024 VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... Potential for positively biased results due to signal reduction over shelf life. Class II Ortho-Clinical Diagnostics, Inc.
Feb 27, 2024 VITROS Performance Verifier II The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifie... Class II Ortho-Clinical Diagnostics
Feb 27, 2024 VITROS Performance Verifier I The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifie... Class II Ortho-Clinical Diagnostics
Feb 7, 2024 DCA Systems HbA1c Reagent Kit The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a po... Class II Siemens Healthcare Diagnostics, Inc.
Jan 30, 2024 MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" 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 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the pe... 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 NI/TU NON-ECHO 2.75" PG- Used for the p... 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 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 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percu... 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 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.

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.