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.

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DateProductReasonClassFirm
Aug 25, 2014 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
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 19, 2014 ADVIA Centaur Immunoassay System (including refurbished units), This syst... The firm has identified an issue with patient demographic information sent to the LIS from the AD... Class II Siemens Healthcare Diagnostics
Aug 19, 2014 ADVIA Centaur XP Immunoassay System (including refurbished units), This s... The firm has identified an issue with patient demographic information sent to the LIS from the AD... Class II Siemens Healthcare Diagnostics
Aug 13, 2014 ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (S... The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... Class II Siemens Healthcare Diagnostics
Aug 13, 2014 ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers... The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... Class II Siemens Healthcare Diagnostics
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 6, 2014 ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems... The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin... Class II Siemens Healthcare Diagnostics
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 5, 2014 CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL... The firm became aware of a potential problem that was initiated by a customer complaint. After c... Class II Curbell Medical, Inc.
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 9, 2014 Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7... An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collim... Class II Carestream Health, Inc.
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
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

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.