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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DateProductReasonClassFirm
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.
Dec 15, 2015 Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. ... The cannulae may bend during procedure. Class II Globalmed Logistix
Dec 9, 2015 MOSAIQ Oncology Information System MOSAIQ is an oncology information syste... Incorrect drug dosage due to "Age Limit" and patient weight data item issue. Class II Elekta, Inc.
Nov 24, 2015 MOSAIQ Oncology Information System. Used to manage workflows for treatment... First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies dr... Class II Elekta, Inc.
Nov 10, 2015 Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling... Improper targeted temperature therapy was delivered to patients because the Temperature Simulator... Class II C.R. Bard, Inc.
Nov 9, 2015 Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The pr... The product may contain electronic components that lead to a premature drainage of the internal c... Class II C.R. Bard, Inc.
Oct 16, 2015 Monaco - Radiation Treatment Planning used to make treatment plans for patie... Unintended update of Dose and MU and Incorrect Assignment of Bolus. Class II Elekta, Inc.
Oct 2, 2015 Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold i... Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Cathet... Class III C.R. Bard, Inc.
Sep 15, 2015 Monaco Radiation Treatment Planning System. Used to make treatment plans f... Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple presc... Class II Elekta, Inc.
Aug 31, 2015 XiO Radiation Treatment Planning System. Used to create treatment plans for ... Incorrect Treatment Delivery Using Third Party Fixed Wedges. Class II Elekta, Inc.
Aug 24, 2015 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Ad... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Produc... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Produc... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Produ... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional T... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 1... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155);... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheos... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 227... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109)... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DS... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product ... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Pro... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, 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.