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 |
|---|---|---|---|---|
| Jul 8, 2019 | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5600 Integrated System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jun 27, 2019 | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01... | The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID... | Class II | Angiodynamics, Inc. |
| Jun 27, 2019 | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative de... | Iincreased (falsely elevated) Albumin results compared to expected results | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the k... | Class II | Epimed International, Inc. |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the... | Class II | Epimed International, Inc. |
| Jun 17, 2019 | VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chem... | Potentially Biased Results using VITROS Chemistry Products GLU Slides | Class II | Ortho-Clinical Diagnostics |
| Jun 11, 2019 | CTSTM Essential 8 Medium | Component was not tested by the supplier for adventitious agents | Class II | Life Technologies Corporation |
| Jun 11, 2019 | StemPro¿ MSC SFM CTS" | Component was not tested by the supplier for adventitious agents | Class II | Life Technologies Corporation |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero G... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Appl... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generat... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 16, 2019 | EyeBOX Model OCL 02 | A review of the user manual revealed that two precaution statements were missing. | Class II | OCULOGICA |
| Apr 8, 2019 | VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) ... | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... | Class II | Ortho-Clinical Diagnostics |
| Apr 8, 2019 | VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 107587... | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... | Class II | Ortho-Clinical Diagnostics |
| Apr 8, 2019 | VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) ... | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... | Class II | Ortho-Clinical Diagnostics |
| Apr 8, 2019 | VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) ... | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... | Class II | Ortho-Clinical Diagnostics |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number:... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | Rifton E-Pacer, SKU K660, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechani... | Class II | Community Products, LLC |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TR... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | Rifton TRAM Low Base, SKU K320, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechani... | Class II | Community Products, LLC |
| Mar 21, 2019 | Rifton TRAM Standard Base, SKU K310, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechani... | Class II | Community Products, LLC |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog N... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: ... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: ... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 20, 2019 | VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 684446... | Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentiall... | Class II | Ortho-Clinical Diagnostics |
| Mar 19, 2019 | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbe... | When the user performs the re-assignment of a parent / companion pair, the parent volume is trans... | Class II | Carestream Health, Inc. |
| Mar 11, 2019 | VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 ... | One of the software algorithms used to detect sample dispense errors was inadvertently disabled. ... | Class II | Ortho-Clinical Diagnostics |
| Mar 7, 2019 | Atellica IM 1300 Analyzer, Material Number 11066001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica Sample Handler Prime, Material Number 11069001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica IM 1600 Analyzer, Material Number 11066000 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 20, 2019 | VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product ... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 684... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use ... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 680278... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Jan 22, 2019 | VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro ... | Imprecision in the affected lot may produce negatively or positively biased patient sample and qu... | Class II | Ortho-Clinical Diagnostics |
| Dec 11, 2018 | VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only... | Negative bias results when using VITROS VALP Reagent, GEN 25. | Class II | Ortho-Clinical Diagnostics |
| Nov 1, 2018 | Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated hi... | lack of 510K | Class II | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Nov 1, 2018 | Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high per... | lack of 510K | Class II | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Nov 1, 2018 | Genesys Analytical Column, REF 01-05-0017 intended to be used with automated ... | lack of 510K | Class II | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Nov 1, 2018 | Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high per... | lack of 510K | Class II | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Nov 1, 2018 | ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with aut... | lack of 510K | Class II | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
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.