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
Aug 1, 2019	LightPod Neo Lasers	This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock ...	Class II	Aerolase Corporation
Aug 1, 2019	LightPod ERA lasers	This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock ...	Class II	Aerolase Corporation
Jul 30, 2019	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 ...	Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19....	Class II	Siemens Healthcare Diagnostics, Inc.
Jul 10, 2019	IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2K...	There is a potential for low discordant progesterone results on a subset of patient samples. A f...	Class II	Siemens Healthcare Diagnostics, Inc.
Jul 10, 2019	IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128	There is a potential for low discordant progesterone results on a subset of patient samples. A f...	Class II	Siemens Healthcare Diagnostics, Inc.
Jul 8, 2019	VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che...	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5600 Integrated System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 350 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 4600 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 4600 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 250AT Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5,1 FS Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che...	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5,1 FS Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 250 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 250 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jul 8, 2019	VITROS 5600 Integrated System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	Class II	Ortho Clinical Diagnostics
Jun 27, 2019	AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01...	The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID...	Class II	Angiodynamics, Inc.
Jun 27, 2019	N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative de...	Iincreased (falsely elevated) Albumin results compared to expected results	Class II	Siemens Healthcare Diagnostics, Inc.
Jun 18, 2019	Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni...	Mislabeled - The product's labeling contains an incorrect size for the catheter included in the k...	Class II	Epimed International, Inc.
Jun 18, 2019	Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni...	Mislabeled - The product's labeling contains an incorrect size for the catheter included in the...	Class II	Epimed International, Inc.
Jun 17, 2019	VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chem...	Potentially Biased Results using VITROS Chemistry Products GLU Slides	Class II	Ortho-Clinical Diagnostics
Jun 11, 2019	CTSTM Essential 8 Medium	Component was not tested by the supplier for adventitious agents	Class II	Life Technologies Corporation
Jun 11, 2019	StemPro¿ MSC SFM CTS"	Component was not tested by the supplier for adventitious agents	Class II	Life Technologies Corporation
Apr 17, 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli...	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero G...	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli...	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Appl...	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generat...	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 16, 2019	EyeBOX Model OCL 02	A review of the user manual revealed that two precaution statements were missing.	Class II	OCULOGICA
Apr 8, 2019	VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) ...	Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst...	Class II	Ortho-Clinical Diagnostics
Apr 8, 2019	VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 107587...	Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst...	Class II	Ortho-Clinical Diagnostics
Apr 8, 2019	VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) ...	Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst...	Class II	Ortho-Clinical Diagnostics
Apr 8, 2019	VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) ...	Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst...	Class II	Ortho-Clinical Diagnostics
Mar 21, 2019	ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number:...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	Rifton E-Pacer, SKU K660, powered lift device	A design change to the load-bearing quick release buckle renders the springs in the latch mechani...	Class II	Community Products, LLC
Mar 21, 2019	ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TR...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	Rifton TRAM Low Base, SKU K320, powered lift device	A design change to the load-bearing quick release buckle renders the springs in the latch mechani...	Class II	Community Products, LLC
Mar 21, 2019	Rifton TRAM Standard Base, SKU K310, powered lift device	A design change to the load-bearing quick release buckle renders the springs in the latch mechani...	Class II	Community Products, LLC
Mar 21, 2019	ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog N...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: ...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: ...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 20, 2019	VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 684446...	Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentiall...	Class II	Ortho-Clinical Diagnostics
Mar 19, 2019	OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbe...	When the user performs the re-assignment of a parent / companion pair, the parent volume is trans...	Class II	Carestream Health, Inc.
Mar 11, 2019	VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 ...	One of the software algorithms used to detect sample dispense errors was inadvertently disabled. ...	Class II	Ortho-Clinical Diagnostics
Mar 7, 2019	Atellica IM 1300 Analyzer, Material Number 11066001	There were multiple issues identified in the system software which required an update.	Class II	Siemens Healthcare Diagnostics, Inc.
Mar 7, 2019	Atellica Sample Handler Prime, Material Number 11069001	There were multiple issues identified in the system software which required an update.	Class II	Siemens Healthcare Diagnostics, Inc.
Mar 7, 2019	Atellica IM 1600 Analyzer, Material Number 11066000	There were multiple issues identified in the system software which required an update.	Class II	Siemens Healthcare Diagnostics, Inc.
Feb 20, 2019	VITROS¿ 3600 Immunoassay 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

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.