Browse Device Recalls
706 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 706 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 706 FDA device recalls in GA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Mar 14, 2013 | Precise Treatment Table. To be used as part of radiation therapy treatment... | The Column rotation can accidentally be moved to a different position which in the locked position. | Class II | Elekta, Inc. |
| Mar 6, 2013 | KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm)... | Some individual container filter units might contain thin areas that may potentially compromise t... | Class II | Kimberly-Clark Corporation |
| Feb 11, 2013 | Monaco RTP System. Radiation treatment planning. | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" a... | Class II | Elekta, Inc. |
| Jan 18, 2013 | Elekta, Apex add-on Micro MLC, collimator for radiation therapy. | If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activ... | Class II | Elekta, Inc. |
| Dec 19, 2012 | Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4... | The DICOM tags do not contain sufficient information for XVI to identify the different volumes th... | Class II | Elekta, Inc. |
| Sep 18, 2012 | MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) u... | A patient was seriously mistreated after a user made and saved an inadvertent change to the defin... | Class II | Elekta, Inc. |
| Sep 7, 2012 | 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The p... | The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (... | Class II | C.R. Bard, Inc., Urological Division |
| Aug 29, 2012 | Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Rem... | Sterility of the product may be compromised. | Class II | Remington Medical Inc. |
| Aug 21, 2012 | Oncentra External Beam 4.1. Radiation treatment planning software designed... | During the planning process the beam weights can be changed by the customers. When the beam weigh... | Class II | Elekta, Inc. |
| Aug 6, 2012 | Precise Digital Accelerator Delivery of radiation to defined target volumes | There have been a small number of instances in hospitals where the joint between the drive gear a... | Class II | Elekta, Inc. |
| Jul 27, 2012 | Multileaf Collimator To be used for single or multiple fractions, delivere... | Information released with the product Agility did not originally contain information on compatibi... | Class II | Elekta, Inc. |
| Jul 5, 2012 | ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a ste... | Package seam of some units may not remain properly sealed to ensure the contents might not be ste... | Class II | Kimberly-Clark Corporation |
| Jul 5, 2012 | MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product... | Package seam of some units may not remain properly sealed to ensure the contents might not be ste... | Class II | Kimberly-Clark Corporation |
| Jul 3, 2012 | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables u... | The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when use... | Class II | OPTI Medical Systems, Inc |
| Jun 29, 2012 | Bard Foley procedural trays packaged in breather bags. The product is packag... | Incomplete seal on sterile packages of product. | Class II | C.R. Bard, Inc., Urological Division |
| Jun 21, 2012 | Monaco Product Usage: Planning of radiation therapy | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... | Class II | Elekta, Inc. |
| Jun 21, 2012 | Focal SIM Planning of radiation therapy | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... | Class II | Elekta, Inc. |
| Apr 27, 2012 | Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly... | A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to los... | Class II | Kimberly-Clark Corporation |
| Apr 27, 2012 | PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surger... | Potential failure in the glued seal between the stem and the tip of the handpiece leading to the ... | Class II | Plasma Surgical Inc. |
| May 1, 2011 | Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The devic... | Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke ... | Class II | Cardiogenesis Corporation |
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.