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
Oct 19, 2018 VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vi... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in th... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 17, 2018 Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Us... Instructions for Use booklets were not included on the outer pouch Class II Numed Inc
Oct 17, 2018 Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Us... Instructions for Use booklets were not included on the outer pouch Class II Numed Inc
Oct 16, 2018 BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL ... specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 16, 2018 Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE ... Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 15, 2018 Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, ... There is a potential for the male connectors on external cables to become damaged. This could inc... Class II Jarvik Heart Inc
Oct 8, 2018 VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to ... VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results Class II Ortho-Clinical Diagnostics
Oct 2, 2018 Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 ... The firm received complaints of the wrap coming apart and leaking granular material Class II Pfizer Inc.
Oct 2, 2018 Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 05733013... The firm received complaints of the wrap coming apart and leaking granular material Class II Pfizer Inc.
Oct 2, 2018 Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Produ... The firm received complaints of the wrap coming apart and leaking granular material Class II Pfizer Inc.
Sep 26, 2018 Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specim... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2018 Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens ... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2018 Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens.... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 26, 2018 Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens ... Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... Class II Siemens Healthcare Diagnostics, Inc.
Sep 18, 2018 SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 If an operator attempts to manually program a Basic Infusion for a drug that is not included in t... Class II Baxter Healthcare Corporation
Sep 12, 2018 Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1... Foreign material in product Class II CMP Industries, Llc
Sep 12, 2018 IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml... Foreign material in product Class II CMP Industries, Llc
Aug 29, 2018 Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compres... The product was designed for 120V usage and is being used in South Africa with 220V. There is a ... Class II SANRAI INTERNATIONAL LLC
Aug 28, 2018 VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number... The reagent pack exhibits the potential for an increased frequency of calibration failures. Class II Ortho-Clinical Diagnostics
Aug 24, 2018 Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vi... Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 15, 2018 VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quan... Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ... Class II Ortho-Clinical Diagnostics
Aug 15, 2018 VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quanti... Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ... Class II Ortho-Clinical Diagnostics
Aug 14, 2018 APTIO CENTRIFUGE MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO 9000 REFRIGERATED STORAGE MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO RACK OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB - REFRIGERATED STORAGE MODULE 15000 The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB - REFRIGERATED STORAGE MODULE 9000 The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO INPUT/OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB CORE UNIT / LYNX WITH IOM The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO RACK INPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO 15000 REFRIGERATED STORAGE MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Jul 24, 2018 BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PL... BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual ste... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Jul 11, 2018 VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage:... The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and L... Class III Ortho-Clinical Diagnostics
Jul 11, 2018 VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage ... The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... Class III Ortho-Clinical Diagnostics
Jul 11, 2018 VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usag... The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and... Class III Ortho-Clinical Diagnostics
Jul 11, 2018 VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage:... The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... Class III Ortho-Clinical Diagnostics
Jul 3, 2018 Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... Vials labeled for the prescriptions contained incorrect lenses Class III Alden Optical
Jul 3, 2018 Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... Vials labeled for the prescriptions contained incorrect lenses Class III Alden Optical
Jun 29, 2018 Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a mult... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, 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.