Browse Device Recalls
273 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 273 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 273 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 18, 2016 | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Uniqu... | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be gene... | Class II | Ortho-Clinical Diagnostics |
| May 16, 2016 | enGen Laboratory Automation System, Product Code engen, Software Versions enG... | If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri... | Class III | Ortho-Clinical Diagnostics |
| May 9, 2016 | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784,... | Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| Apr 19, 2016 | The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunctio... | There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will pr... | Class III | Ortho-Clinical Diagnostics |
| Apr 6, 2016 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2016 | VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Mar 17, 2016 | enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... | The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... | Class II | Ortho-Clinical Diagnostics |
| Feb 18, 2016 | 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique ... | When testing was conducted using certain lots, VITROS¿ Systems generated results within the measu... | Class II | Ortho-Clinical Diagnostics |
| Feb 16, 2016 | VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & ... | The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situ... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 1... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Sep 28, 2015 | VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 85... | The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes ... | Class III | Ortho-Clinical Diagnostics |
| Sep 10, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... | Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versio... | Class II | Ortho-Clinical Diagnostics |
| Jun 30, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... | Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2015 | enGen Laboratory Automation System (enGen System), Product Code ENGEN, config... | Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of ent... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2015 | VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique... | The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank lab... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| Apr 6, 2015 | VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | Assay Data Disk (ADD), All DRV versions that support product within expiry da... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Mar 10, 2015 | Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Numb... | Software Anomaly; It is possible for the device to process samples with a cartridge other than th... | Class II | Ortho-Clinical Diagnostics |
| Dec 29, 2014 | VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the fo... | In combination with the Batch Programming option (only) for programming samples, the hand-held ba... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Nu... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho C... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 6, 2014 | VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro di... | Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides. | Class II | Ortho-Clinical Diagnostics |
| Sep 29, 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis... | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod... | Class III | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | VITROS 5600 Integrated System, System Product Code 6802413. For use in the... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Aug 20, 2014 | VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671,... | Ortho Clinical Diagnostics identified a potential for biased results to be generated when using V... | Class II | Ortho-Clinical Diagnostics |
| Aug 6, 2014 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitati... | VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Jul 16, 2014 | VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot ... | Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 1... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Jul 15, 2014 | VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and... | Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Cali... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VIT... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative,... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| May 12, 2014 | VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6... | Calibrator values assigned for the calibrator kit lots were released using a reference method tha... | Class II | Ortho-Clinical Diagnostics |
| May 12, 2014 | VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number... | Calibrator values assigned for the calibrator kit lots were released using a reference method tha... | Class II | Ortho-Clinical Diagnostics |
| Apr 17, 2014 | enGen (TM) Laboratory Automation System Configured with TCAutomation" Softwar... | Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Sys... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in v... | Potential for biased results when a Multiple Window (MW) code is associated with results generate... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vit... | Potential for biased results when a Multiple Window (MW) code is associated with results generate... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vit... | Software anomaly: potential for delay in the reporting of patient sample test results when using ... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/... | Potential for biased results when a Multiple Window (MW) code is associated with results generate... | 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.