Browse Device Recalls

676 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 676 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 676 FDA device recalls in GA.

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Date	Product	Reason	Class	Firm
Nov 3, 2014	MOSAIQ Product Usage: MOSAIQ is an oncology information system used to ma...	A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose ro...	Class II	Elekta, Inc.
Oct 7, 2014	Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone baske...	The product is non-sterile.	Class II	C.R. Bard, Inc.
Oct 6, 2014	Laksell Gamma Knife Perfexion	Elekta has become aware that the latches may be locked before they have been fully turned resulti...	Class II	Elekta, Inc.
Aug 27, 2014	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic mon...	Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglo...	Class II	Mckesson Information Solutions LLC
Aug 18, 2014	Monaco The Monaco system is used to make treatment plans for patients wit...	Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic ...	Class II	Elekta, Inc.
Aug 18, 2014	FOCAL Sim Workstation, Radiation Treatment Planning System. Used for pat...	When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Com...	Class II	Elekta, Inc.
Jun 25, 2014	McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for comple...	McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to es...	Class II	Mckesson Information Solutions LLC
May 29, 2014	MOSAIQ MOSAIQ is an oncology information system used to manage workflows f...	MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other t...	Class II	Elekta, Inc.
May 29, 2014	iGUIDE System Product Usage: The intended use of the device is the contro...	A bug in the software prevents the iGUIDE software from logging off.	Class II	Elekta, Inc.
May 23, 2014	MOSAIQ, an oncology information system used to manage workflows for treatment...	When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and th...	Class II	Elekta, Inc.
Apr 25, 2014	BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (Bio...	Serum albumin component monomer failed to meet internally established end of shelf-life specifica...	Class II	CryoLife, Inc.
Apr 23, 2014	Synergy XVI Intended for radiation therapy treatment.	XVI can incorrectly calculate the target position of the treatment table.	Class II	Elekta, Inc.
Apr 17, 2014	HexaPOD evo RT Couchtop. To support and aid in positioning a patient durin...	If screws are not properly tightened with a torque wrench they may become loose over time.	Class II	Elekta, Inc.
Mar 5, 2014	FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. El...	Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically...	Class II	Remington Medical Inc.
Feb 17, 2014	XiO RPT System The XiO RTP System is used to create treatment plans for an...	Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used wit...	Class II	Elekta, Inc.
Feb 12, 2014	On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indi...	Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 ...	Class II	CryoLife, Inc.
Feb 3, 2014	Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega...	Firm is not registered as a drug manufacturer.	Class II	Altasource LLC dba Meta Labs LLC
Feb 3, 2014	Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA ...	Firm is not registered as a drug manufacturer.	Class II	Altasource LLC dba Meta Labs LLC
Feb 3, 2014	Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8...	Firm is not registered as a drug manufacturer.	Class II	Altasource LLC dba Meta Labs LLC
Feb 3, 2014	Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical g...	Firm is not registered as a drug manufacturer.	Class II	Altasource LLC dba Meta Labs LLC
Dec 23, 2013	Horizon Medical Imaging, Picture Archive Communication System (PACS).	Images may be archived to an incorrect or invalid archive location resulting in incorrect images ...	Class II	Mckesson Information Solutions LLC
Dec 20, 2013	Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set...	Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to be...	Class II	Perrigo Diabetes Care
Nov 25, 2013	Synergy XVI XVI can incorrectly calculate the target position of the treat...	XVI can incorrectly calculate the target position of the treatment table.	Class II	Elekta, Inc.
Nov 25, 2013	Agility. Version 3.1 of the Integrity interface and control software for the...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	Synergy XVI The Elekta Synergy S is intended to be used for radiation ther...	Potential collision risk when using XVI and external beam shaping devices.	Class II	Elekta, Inc.
Nov 25, 2013	RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user in...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	XiO RTP System. Used to create treatment plans for any cancer patient for ...	When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Sourc...	Class II	Elekta, Inc.
Nov 25, 2013	Integrity. Version 1.1 of the Integrity interface and control software for t...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	Desktop Pro TM linear accelerator control software intended to assist a licen...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 25, 2013	XiO RTP System The XiO RTP System is used to create treatment plans for an...	When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded...	Class II	Elekta, Inc.
Nov 25, 2013	Agility. Version 3.0 of the Integrity interface and control software for the...	During the treatment table, gantry, and collimator calibration procedures, it is possible to type...	Class II	Elekta, Inc.
Nov 22, 2013	Pulmonary Hemi-Artery SG Used in heart surgery	Serological testing for the donor was performed with a blood sample that may have been hemodilute...	Class II	CryoLife, Inc.
Oct 29, 2013	Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Ac...	Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated...	Class II	Kimberly-Clark Corporation
Oct 24, 2013	Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD L...	Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer...	Class II	Kimberly-Clark Corporation
Oct 15, 2013	McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).	When merging two patient records into one patient record using McKesson Radiology 12.0, the resul...	Class II	Mckesson Information Solutions LLC
Sep 4, 2013	McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, ...	Software malfunction may occur resulting in a certain combination of server configurations which ...	Class II	Mckesson Information Solutions LLC
Aug 15, 2013	DMLC IV-ERGO - Beam shaping block for Radiation Therapy.	Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are i...	Class II	Elekta, Inc.
Aug 9, 2013	Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTI...	OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could pe...	Class II	OPTI Medical Systems, Inc
Jul 25, 2013	DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone softw...	An anomaly was detected such that, under certain conditions, a summed dose created by Velocity re...	Class II	Velocity Medical Solutions, LLC
Jul 23, 2013	Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories ...	Potential for clinical errors.	Class II	Elekta, Inc.
Jul 22, 2013	Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Prod...	The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was...	Class II	MCKESSON TECHNOLOGIES INC
Jul 2, 2013	Monaco RTP System Radiation treatment planning	Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch ...	Class II	Elekta, Inc.
Jun 11, 2013	AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cab...	The RITA Main Cable product contains the incorrect Instructions for Use.	Class II	Angiodynamics, INC
May 28, 2013	SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation th...	Customers are resetting the default values outside recommended factory settings.	Class II	Elekta, Inc.
May 28, 2013	All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2...	Customers are resetting the default values outside recommended factory settings.	Class II	Elekta, Inc.
May 22, 2013	Monaco RTP System Radiation Therapy Treatment Planning System. Radiation ...	Patient needs to be positioned as indicated by the treatment plan.	Class II	Elekta, Inc.
May 1, 2013	DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear ...	It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems	Class II	Elekta, Inc.
Apr 30, 2013	Integrity 3.0 Product Usage: The Agility multileaf collimator is indicate...	Unexpected movement during beam delivery may not be detected if there are incorrect static tolera...	Class II	Elekta, Inc.
Apr 4, 2013	ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in t...	Expiration date on the patient label and date on the product carton were not the same.	Class II	Medshape Solutions, INC.
Mar 28, 2013	Integrity 1.1. Integrity is the interface and control software for the Ele...	The problem is that the "static tolerances" from the calibration files (loaded database) are used...	Class II	Elekta, 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.