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
May 24, 2016	VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used ...	Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VI...	Class III	Ortho-Clinical Diagnostics
May 18, 2016	VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Uniqu...	Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be gene...	Class II	Ortho-Clinical Diagnostics
May 18, 2016	Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Bi...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtche...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10'...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.0...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 16, 2016	enGen Laboratory Automation System, Product Code engen, Software Versions enG...	If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri...	Class III	Ortho-Clinical Diagnostics
Apr 28, 2016	IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ...	Possible presence of foreign material (rust).	Class II	CMP Industries, Llc
Apr 28, 2016	ADVIA Centaur XPT Immunoassay System	The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) ...	Class II	Siemens Healthcare Diagnostics, Inc.
Apr 28, 2016	IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454...	Possible presence of foreign material (rust).	Class II	CMP Industries, Llc
Apr 22, 2016	15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the ep...	There is a possibility that the needles may have the potential to skive a catheters outer coatin...	Class II	Epimed International, Inc.
Apr 19, 2016	The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunctio...	There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will pr...	Class III	Ortho-Clinical Diagnostics
Apr 15, 2016	IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insu...	24 minutes of incubation is required prior to processing patient samples and for the pretreatment...	Class II	Siemens Healthcare Diagnostics, Inc.
Apr 15, 2016	CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490...	Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita...	Class II	Carestream Health Inc
Apr 15, 2016	CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1...	Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita...	Class II	Carestream Health Inc
Apr 6, 2016	VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in...	Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ...	Class II	Ortho-Clinical Diagnostics
Apr 6, 2016	VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi...	Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ...	Class II	Ortho-Clinical Diagnostics
Mar 30, 2016	ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,...	The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina...	Class III	Siemens Healthcare Diagnostics, Inc.
Mar 30, 2016	AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./...	The product lot did not meet sterility requirements based on FDA sampling and analysis.	Class II	Amd-Ritmed, Inc.
Mar 21, 2016	AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870,...	Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 21, 2016	Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Us...	Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 17, 2016	enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec...	The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l...	Class II	Ortho-Clinical Diagnostics
Mar 14, 2016	BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Ki...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M0014...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN ...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H96595...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H96595...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M0014...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55c...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & ...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, R...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels:...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H9654...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, ...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016	Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96...	PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe...	Class II	Navilyst Medical, Inc., an AngioDyamics Company
Mar 10, 2016	ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD ...	Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology S...	Class II	Siemens Healthcare Diagnostics, Inc.
Mar 10, 2016	HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles,...	On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,...	Class II	Repro-Med Systems, Inc.
Mar 10, 2016	Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60,...	On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,...	Class II	Repro-Med Systems, Inc.
Mar 7, 2016	ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 1069757...	Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagen...	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.