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 |
|---|---|---|---|---|
| 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 |
| Jul 2, 2014 | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynare... | "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if... | Class II | Dynarex Corporation |
| Jul 2, 2014 | Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DE... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health Inc. |
| Jul 2, 2014 | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health Inc. |
| Jun 4, 2014 | PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Sin... | Possible leak from the filter allowing a small of amount of air to be released from the junction ... | Class II | Pall Corporation |
| May 30, 2014 | KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and... | A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Tec... | Class II | Carestream Health Inc. |
| 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 |
| May 8, 2014 | MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. Th... | ConMed Corporation has received complaints regarding sparking, no output and burning at the cord ... | Class II | ConMed Corporation |
| 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 14, 2014 | bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The access... | A stock check revealed broken glass fibers between the connector and the fiber bundle in a large ... | Class II | Ivoclar Vivadent, Inc. |
| 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 |
| Mar 26, 2014 | VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15... | Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Prote... | Class II | Ortho-Clinical Diagnostics |
| Mar 26, 2014 | VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- ... | Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Prote... | Class II | Ortho-Clinical Diagnostics |
| Mar 20, 2014 | enGen (TM) Laboratory Automation System configured with Data Innovations, LLC... | Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires fol... | Class II | Ortho-Clinical Diagnostics |
| Mar 5, 2014 | VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Di... | The firm identified a potential for biased carbamazepine (CRBM) results to be generated when usin... | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2014 | Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1... | ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion... | Class II | ConMed Corporation |
| Feb 20, 2014 | VITROS TT4 Calibrator For the quantitative measurement of total thyroxine ... | Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. | Class II | Ortho-Clinical Diagnostics |
| Feb 18, 2014 | ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyze... | Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and f... | Class II | Siemens Healthcare Diagnostics |
| Jan 29, 2014 | VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalo... | Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Prod... | Class II | Ortho-Clinical Diagnostics |
| Jan 24, 2014 | Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 53... | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-... | Class II | Carestream Health Inc. |
| Jan 24, 2014 | Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- ... | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-... | Class II | Carestream Health Inc. |
| Jan 15, 2014 | VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATAL... | Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin... | Class III | Ortho-Clinical Diagnostics |
| Jan 9, 2014 | VITROS Chemistry Products White Reference Slides, White Correction Factor Sli... | An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (fi... | Class II | Ortho-Clinical Diagnostics |
| Dec 26, 2013 | KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by... | Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software ... | Class II | Carestream Health, Inc. |
| Dec 20, 2013 | IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, S... | Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha... | Class II | Siemens Healthcare Diagnostics |
| Dec 20, 2013 | IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380... | Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the... | Class II | Siemens Healthcare Diagnostics |
| Dec 20, 2013 | Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utiliz... | Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on S... | Class II | Zeiss, Carl Inc |
| Dec 20, 2013 | IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SM... | Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha... | Class II | Siemens Healthcare Diagnostics |
| Dec 20, 2013 | IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD -... | Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the... | Class II | Siemens Healthcare Diagnostics |
| Nov 25, 2013 | DRX-Evolution with FF WS These products are permanently installed diagnost... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an... | Class II | Carestream Health, Inc. |
| Nov 25, 2013 | DRX-Evolution with CSH WS These products are permanently installed diagnos... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an... | Class II | Carestream Health, Inc. |
| Nov 25, 2013 | DR 7500 with FF WS These products are permanently installed diagnostic x-r... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an... | Class II | Carestream Health, Inc. |
| Nov 20, 2013 | ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses ... | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... | Class II | CooperVision Inc. |
| Nov 20, 2013 | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses,... | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... | Class II | CooperVision Inc. |
| Nov 18, 2013 | IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 ... | During the current inspection of CMP Industries, the FDA Investigator discovered that the firm ha... | Class II | CMP Industries, Llc |
| Nov 6, 2013 | IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ... | potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000... | Class II | Siemens Healthcare Diagnostics |
| Oct 25, 2013 | VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P... | Class II | Ortho-Clinical Diagnostics |
| Oct 23, 2013 | ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaf... | The affected lots were exposed to a higher than acceptable level of particulate matter during man... | Class II | ConMed Corporation |
| Oct 23, 2013 | ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaf... | The affected lots were exposed to a higher than acceptable level of particulate matter during man... | Class II | ConMed Corporation |
| Oct 17, 2013 | VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Di... | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K... | Class II | Ortho-Clinical Diagnostics |
| Oct 17, 2013 | VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnost... | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K... | Class II | Ortho-Clinical Diagnostics |
| Oct 10, 2013 | VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chem... | Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing C... | Class II | Ortho-Clinical Diagnostics |
| Oct 9, 2013 | VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/... | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P... | Class II | Ortho-Clinical Diagnostics |
| Oct 8, 2013 | enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5... | Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... | Class II | Ortho-Clinical Diagnostics |
| Oct 8, 2013 | enGen Track System with enGen Select v5.0 with autoverification enabled Pr... | Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... | 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.