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 |
|---|---|---|---|---|
| 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.