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 2, 2016 | MOSAIQ Oncology Information System The product is used to manage workflow... | Edits to Particle field definition parameters may not be saved when the field definition window i... | Class II | Elekta, Inc. |
| Nov 22, 2016 | Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plat... | There is a problem with the mating feature between the plate and screw which could cause the plat... | Class II | Amendia, Inc |
| Nov 22, 2016 | Ceres-C Standalone Cervical Interbody The product is a stand-alone anterio... | Absent tantalum market pin. | Class II | Amendia, Inc |
| Nov 22, 2016 | Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Ro... | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... | Class II | Amendia, Inc |
| Nov 22, 2016 | Optimus Fixed Awl | Complaints that the tip of the awl broke after impaction during surgery. | Class II | Amendia, Inc |
| Nov 22, 2016 | Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through ... | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... | Class II | Amendia, Inc |
| Nov 22, 2016 | Zeus-P Lumbar Interbody Device | Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluat... | Class II | Amendia, Inc |
| Nov 22, 2016 | Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm ... | There is a problem with the mating feature between the plate and screw which could cause the plat... | Class II | Amendia, Inc |
| Nov 22, 2016 | K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm... | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... | Class II | Amendia, Inc |
| Nov 21, 2016 | CryoPatch SG Pulmonary Hemi-Artery Patch | The device is recalled due to donor ineligibility of released human tissue. The firm received inf... | Class II | CryoLife, Inc. |
| Nov 17, 2016 | Monaco TRP System The Monaco system is used to make treatment plans for pati... | Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of ... | Class II | Elekta, Inc. |
| Nov 10, 2016 | Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. | Defects: Product may be discolored and brittle resulting in the inability of the user to don the ... | Class II | Halyard Health |
| Nov 9, 2016 | Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Prod... | Drapes within the affected lots may include a manufacturing variation that prevents convenient re... | Class II | Halyard Health, Inc |
| Nov 3, 2016 | Monaco RTP System; Used to make treatment plans for patients with prescriptio... | Incorrect Dose when using the reset function. | Class II | Elekta, Inc. |
| Oct 13, 2016 | Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral... | Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... | Class II | C.R. Bard, Inc. |
| Oct 13, 2016 | Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coi... | Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... | Class II | C.R. Bard, Inc. |
| Oct 13, 2016 | BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covingt... | Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... | Class II | C.R. Bard, Inc. |
| Oct 13, 2016 | Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Co... | Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... | Class II | C.R. Bard, Inc. |
| Oct 12, 2016 | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE... | Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. | Class II | C.R. Bard, Inc. |
| Oct 12, 2016 | C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Steri... | Defect; The contact part could possibly separate from the electrode affecting to functionality of... | Class II | C.R. Bard, Inc. |
| Oct 5, 2016 | Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box),... | Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instea... | Class II | C.R. Bard, Inc. |
| Sep 29, 2016 | Monaco RTP System The Monaco system is used to make treatment plans for pati... | When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician... | Class II | Elekta, Inc. |
| Aug 18, 2016 | Monaco RTP System Used to make treatment plans for patients with prescript... | In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the con... | Class II | Elekta, Inc. |
| Aug 18, 2016 | HexaPOD evo RT System Product Usage: The intended use of the device is th... | Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaP... | Class II | Elekta, Inc. |
| Aug 9, 2016 | MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter... | The multi-sample needle retractable sheath may not fully retract over the needle during the chang... | Class II | Global Healthcare Inc |
| Aug 3, 2016 | BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe i... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available ... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adap... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, T... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Jul 15, 2016 | MOSAIQ Oncology Information System | It is possible that a change to an Order Set will not be saved in the current open Care Plan. Thi... | Class II | Elekta, Inc. |
| Jul 11, 2016 | Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. | During an FDA inspection it was found out that the Practical Foley Catheters to be potentially no... | Class II | C.R. Bard, Inc. |
| Jul 11, 2016 | SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK S... | The product contained a latex catheter instead of a silicone catheter. | Class II | C.R. Bard, Inc. |
| Jul 11, 2016 | Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only. | During an FDA inspection it was found out that the Practical Foley Catheters to be potentially no... | Class II | C.R. Bard, Inc. |
| Jul 8, 2016 | Medical Linear Accelerator | There have been instances in hospitals where the joint between the drive gear and the gantry base... | Class II | Elekta, Inc. |
| Jun 30, 2016 | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incuba... | An internal review of an available product found that the Information For Use only contained Engl... | Class III | C.R. Bard, Inc. |
| Jun 29, 2016 | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK St... | Labeling problem | Class III | C.R. Bard, Inc. |
| Jun 17, 2016 | MOSAIQ Oncology Information System | It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling th... | Class II | Elekta, Inc. |
| Jun 16, 2016 | Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conj... | Mismatch between the length of the RF electrode (probe) and the cannula (introducer), | Class II | Halyard Health, Inc |
| May 18, 2016 | Monaco RTP System Product Usage: The Monaco system is used to make treatm... | When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is sele... | Class II | Elekta, Inc. |
| May 12, 2016 | iGUIDE System, for patient positioning, with assistance of a 30 Tracking Syst... | If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the... | Class II | Elekta, Inc. |
| Apr 19, 2016 | Radionuclide Radiation Therapy System Product The product is a teletherapy... | The latches of the frame adapter can be locked even if the locating pins of the frame adapter is ... | Class II | Elekta, Inc. |
| Mar 4, 2016 | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management ... | Complaints were received of restricted/inaccurate flow rate. | Class II | C.R. Bard, Inc. |
| Feb 19, 2016 | Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, ... | Customer complaints of very weak reactions with the kit, or false negative results with different... | Class II | Integrated Science Systems Inc |
| Jan 6, 2016 | ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposabl... | Firm was notified of a potential product defect related to kinking (flattening) of anesthesia ext... | Class II | Global Healthcare Inc |
| Jan 4, 2016 | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapte... | Report by a customer of an open package seal. | Class III | C.R. Bard, Inc. |
| Dec 18, 2015 | Oncentra External Beam - VMAT - Radiation therapy planning system Product ... | When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare... | Class II | Elekta, Inc. |
| Dec 18, 2015 | BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model... | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | Class II | C.R. Bard, Inc. |
| Dec 18, 2015 | BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for u... | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | Class II | C.R. Bard, Inc. |
| Dec 18, 2015 | BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bla... | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | Class II | C.R. Bard, Inc. |
| Dec 18, 2015 | Fuse 1C Colonoscope | The bending section of the device may partially separate from the insertion tube. Potential for t... | Class II | EndoChoice, 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.