Browse Device Recalls
1,398 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,398 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 1,398 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2021 | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover ... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cove... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-08... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Hays Ultrasound kit Item ID: H1000SE | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 27, 2021 | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) c... | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c... | Class II | Circulatory Technology Inc. |
| Apr 22, 2021 | ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount m... | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... | Class II | Welch Allyn Inc |
| Apr 22, 2021 | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall ... | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... | Class II | Welch Allyn Inc |
| Mar 26, 2021 | INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibia... | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... | Class II | ConMed Corporation |
| Mar 26, 2021 | VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black R... | Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly l... | Class II | Ortho-Clinical Diagnostics, INc. |
| Mar 26, 2021 | KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibi... | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... | Class II | ConMed Corporation |
| Mar 19, 2021 | Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the cont... | Potentially defective component in the AC power adapter which may fail over time. | Class II | Baxter Healthcare Corporation |
| Mar 17, 2021 | Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: ... | Positive Control may run high out of its assigned ISR range and result in an invalid run and nece... | Class II | Clark Laboratories, Inc. |
| Mar 5, 2021 | ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematolog... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology a... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
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.