Browse Device Recalls

530 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 530 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 530 FDA device recalls.

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Date	Product	Reason	Class	Firm
Sep 22, 2016	Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:...	O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate...	Class II	Medtronic Navigation, Inc.-Littleton
Sep 15, 2016	Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) i...	Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with ...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 16, 2016	Pathfast D-Dimer, Reference number: PF1051-KUS	Two complaints were received about decrease in sensitivity (control value and/or calibration valu...	Class II	Lsi Medience Corporation
Aug 15, 2016	Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribut...	A reagent stability issue (still under investigation) causes less separation in the calibration c...	Class II	Microgenics Corporation
Aug 9, 2016	ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system u...	Possible injury due to movement of the arm, calibration loss and communication loss.	Class II	Swissray Medical
Jul 28, 2016	VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product...	A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than ex...	Class III	ORTHO-CLINICAL DIAGNOSTICS
Jun 22, 2016	Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ...	Software defect, where either an Above Assay Range or an inaccurate value could potentially be re...	Class II	Siemens Healthcare Diagnostics Inc
Jun 1, 2016	PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoeni...	BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the fol...	Class III	Becton Dickinson & Co.
Jun 1, 2016	PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix ...	BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following...	Class III	Becton Dickinson & Co.
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 5, 2016	The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration...	Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the...	Class III	Siemens Healthcare Diagnostics, Inc.
May 5, 2016	Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser ...	Failure to provide the required instructions specifying a procedure and schedule for calibration ...	Class II	Ellipse A/S
May 5, 2016	Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Produ...	Failure to provide the required instructions specifying a procedure and schedule for calibration ...	Class II	Ellipse A/S
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 22, 2016	BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePo...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoin...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph True...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph T...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph Tru...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph Tru...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph Tru...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph T...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePo...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TrueP...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TrueP...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph T...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePo...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TrueP...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Bio...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens ...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biogr...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Bi...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TrueP...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph Tr...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph Tru...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TrueP...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biog...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biog...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph Tru...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph Tru...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TrueP...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemen...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA Inc.
Apr 22, 2016	BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph Tru...	Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v...	Class II	Siemens Medical Solutions USA 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 6, 2016	Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model ...	If used, the optional Swap feature copies programming parameters from the external pulse generato...	Class II	Nuvectra
Mar 25, 2016	The Plum 360 is a large volume infuser capable of delivering fluids for a var...	Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att...	Class II	Hospira 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.