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 5, 2021 ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematol... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematolo... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, aut... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematol... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology a... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology a... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated he... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated h... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated h... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, aut... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 2, 2021 BCS XP System: Multipurpose system for in vitro coagulation studies. Product ... Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected... Class II Siemens Healthcare Diagnostics, Inc.
Feb 22, 2021 Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Feb 22, 2021 AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Feb 18, 2021 VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only).... Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will sta... Class II Ortho-Clinical Diagnostics, Inc.
Feb 12, 2021 VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnos... VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using ... Class II Ortho-Clinical Diagnostics, Inc.
Feb 12, 2021 VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products... VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using ... Class II Ortho-Clinical Diagnostics, Inc.
Feb 1, 2021 Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter ... Outer coating of the catheter may deteriorate and result in the coating to crack and/or potential... Class II Epimed International, Inc.
Jan 22, 2021 Radiation therapy software, RayStation standalone software treatment planning... A software bug affecting results when using deep learning (DL) segmentation followed by geometric... Class II RaySearch America Inc
Jan 14, 2021 VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples... A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips ... Class II Ortho-Clinical Diagnostics, Inc.
Jan 6, 2021 Infusion Pump Battery performance issues related to prolonged storage. Class II Baxter Healthcare Corporation
Dec 2, 2020 Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens... Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... Class II Siemens Healthcare Diagnostics, Inc.
Dec 2, 2020 Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens.... Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... Class II Siemens Healthcare Diagnostics, Inc.
Dec 2, 2020 Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens... Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... Class II Siemens Healthcare Diagnostics, Inc.
Nov 23, 2020 ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro ... Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonst... Class II Siemens Healthcare Diagnostics, Inc.
Nov 23, 2020 Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vit... Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonst... Class II Siemens Healthcare Diagnostics, Inc.
Nov 20, 2020 VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 20, 2020 enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN ... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 12, 2020 Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic pr... Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c... Class II ConMed Corporation
Nov 12, 2020 Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic pr... Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c... Class II ConMed Corporation
Nov 11, 2020 Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001... The device was assembled with the incorrect exhalation port which can cause gas leakage. Class II Intersurgical Inc
Oct 26, 2020 Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers d... Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef b... Class II Siemens Healthcare Diagnostics, Inc.
Oct 26, 2020 Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers d... Test Definition scanning may reset custom settings to defaults causing falsely low or high result... Class II Siemens Healthcare Diagnostics, Inc.
Oct 14, 2020 Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous ... 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator co... Class II Angiodynamics, Inc.
Sep 29, 2020 v|tome|x L Series non-destructive testing cabinet x-ray systems It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning si... Class II Ge Inspection Technologies Llc
Sep 22, 2020 Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the qu... Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra... Class II Siemens Healthcare Diagnostics, Inc.
Sep 22, 2020 ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in th... Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra... Class II Siemens Healthcare Diagnostics, Inc.
Sep 17, 2020 LOM Disposable Surgical Gowns/Medical Gowns, Single-Use Medical gowns distributed to customers did not include appropriate labeling, and some gowns may n... Class II THREAD COUNSEL INC DBA LAWS OF MOTION
Jul 20, 2020 VITROS XT3400 Chemistry System, Product code 6844458 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A... Class II Ortho Clinical Diagnostics
Jul 20, 2020 VITROS XT7600 Integrated System, Product code 6844461 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A... Class II Ortho Clinical Diagnostics
Jul 17, 2020 VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6... The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... Class II Ortho Clinical Diagnostics
Jul 17, 2020 VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog numbe... The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... Class II Ortho Clinical Diagnostics
Jul 13, 2020 VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS ... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
Jul 13, 2020 VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic q... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics

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.