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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jul 13, 2020 | VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro... | Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... | Class II | Ortho-Clinical Diagnostics |
| Jun 26, 2020 | PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat pati... | While operating the machine in "Run" mode an unexcepted event may occur during the error-checking... | Class II | Precision Valve & Automation,Inc |
| Jun 18, 2020 | Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- R... | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Chembio Diagnostics, Inc |
| Jun 18, 2020 | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for th... | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Chembio Diagnostics, Inc |
| Jun 18, 2020 | Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapi... | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Chembio Diagnostics, Inc |
| Jun 5, 2020 | Atellica CH Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 5, 2020 | ADVIA Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 20, 2020 | VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Un... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | VITROS 5600 Integrated System Software Versions 3.3.3 and below Product C... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Produ... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Produc... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 15, 2020 | (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN)... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2020 | (1) CentraLink Data Management System software version 16.0.2 Siemens Materia... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 11, 2020 | VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product... | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... | Class II | Ortho-Clinical Diagnostics |
| May 11, 2020 | VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #... | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... | Class II | Ortho-Clinical Diagnostics |
| May 11, 2020 | VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Produc... | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... | Class II | Ortho-Clinical Diagnostics |
| May 11, 2020 | VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # ... | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... | Class II | Ortho-Clinical Diagnostics |
| May 7, 2020 | Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00... | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 7, 2020 | Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00... | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 4, 2020 | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: Thes... | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... | Class II | Angiodynamics, 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.