Browse Device Recalls

1,361 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,361 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 1,361 FDA device recalls in NY.

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Date	Product	Reason	Class	Firm
Feb 20, 2019	VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 684...	Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems	Class II	Ortho-Clinical Diagnostics
Feb 20, 2019	VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For...	Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems	Class II	Ortho-Clinical Diagnostics
Feb 20, 2019	VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product...	Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems	Class II	Ortho-Clinical Diagnostics
Feb 20, 2019	VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802...	Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems	Class II	Ortho-Clinical Diagnostics
Feb 20, 2019	VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use ...	Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems	Class II	Ortho-Clinical Diagnostics
Feb 20, 2019	VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 680278...	Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems	Class II	Ortho-Clinical Diagnostics
Jan 22, 2019	VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro ...	Imprecision in the affected lot may produce negatively or positively biased patient sample and qu...	Class II	Ortho-Clinical Diagnostics
Dec 11, 2018	VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only...	Negative bias results when using VITROS VALP Reagent, GEN 25.	Class II	Ortho-Clinical Diagnostics
Nov 1, 2018	Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated hi...	lack of 510K	Class II	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018	Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high per...	lack of 510K	Class II	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018	Genesys Analytical Column, REF 01-05-0017 intended to be used with automated ...	lack of 510K	Class II	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018	Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high per...	lack of 510K	Class II	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018	ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with aut...	lack of 510K	Class II	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
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.

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.