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.

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DateProductReasonClassFirm
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
Oct 7, 2015 ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical... Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is... Class II Siemens Healthcare Diagnostics, Inc.
Oct 2, 2015 Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting S... The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrec... Class II Welch Allyn Inc
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 14, 2015 CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Pr... CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels wh... Class III Biochemical Diagnostics Inc
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
Sep 3, 2015 BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biot... The firm determined that 25 lots had been manufactured with a minor surface defect occurring in t... Class II Bausch & Lomb Inc Irb
Aug 28, 2015 ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 1072303... ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the r... Class II Siemens Healthcare Diagnostics, Inc.
Aug 7, 2015 CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a per... Software defect that impacts image alignment when using the automatic stitching option for long l... Class II Carestream Health Inc
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to m... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to meas... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to mea... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to ... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to m... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to ... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to mea... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 9, 2015 IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 6... Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restoration... Class II Ivoclar Vivadent, Inc.
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
Jun 17, 2015 Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduc... Probe programming error. The incorrect program can generate more heat at the surgical site, resu... Class II ConMed Corporation
May 13, 2015 Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression t... Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for... Class II Advanced Back Technologies, Inc.
May 13, 2015 Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for tra... Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for... Class II Advanced Back Technologies, Inc.
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 IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (... IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to s... Class II Siemens Healthcare Diagnostics, Inc.
Apr 9, 2015 IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement... IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parame... Class II Siemens Healthcare Diagnostics, Inc.
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
Apr 2, 2015 MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma dete... The probability and histogram data within the Melafind's device displayed user interface lacks ap... Class II MELA Sciences, Inc.
Mar 23, 2015 ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. Siemens internal investigation confirmed that current contamination avoidance settings do not pre... Class II Siemens Healthcare Diagnostics, Inc.
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
Feb 17, 2015 Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemod... Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condit... Class II Transonic Systems Inc
Feb 11, 2015 ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Versio... Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1... Class II Siemens Healthcare Diagnostics, Inc.
Jan 19, 2015 ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the... Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot ... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 6010... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog N... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965P... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog N... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No.... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, 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.