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
Sep 16, 2013 Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS ... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 3, 2013 ADVIA 2400 System Software V4.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1800 System Software V2.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Aug 29, 2013 Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream... It was discovered that Carestream received a report from a customer that 2 different patients wer... Class II Carestream Health Inc.
Aug 29, 2013 DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. b... Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... Class II Carestream Health Inc.
Aug 29, 2013 CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A.... Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... Class II Carestream Health Inc.
Aug 27, 2013 T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material N... Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ... Class II Siemens Healthcare Diagnostics
Aug 27, 2013 Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay f... Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Aug 27, 2013 T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 1... Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ... Class II Siemens Healthcare Diagnostics
Aug 20, 2013 Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Sta... Carestream received a report of an exposure being initiated without a patient image captured. The... Class II Carestream Health Inc.
Aug 12, 2013 ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN... Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120... Class II Siemens Healthcare Diagnostics
Aug 2, 2013 Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50... AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viabil... Class II Getinge USA Inc
Jul 30, 2013 ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/US... Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up t... Class II Siemens Healthcare Diagnostics
Jul 26, 2013 DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY... During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an a... Class II Carestream Health, Inc.
Jun 26, 2013 PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog N... Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the... Class II Siemens Healthcare Diagnostics
Jun 26, 2013 ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . ... The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When th... Class II Siemens Healthcare Diagnostics
Jun 19, 2013 DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, ... Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolut... Class II Carestream Health Inc.
Jun 12, 2013 VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog numbe... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 ... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 ... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog nu... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog numbe... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog numbe... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog numbe... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... 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.