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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.