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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
May 18, 2015 The VariSource iX series afterloader systems are computer controlled remote e... After an application freeze and restart of the VariSource iX series by power cycling, the Partial... Class II Varian Medical Systems Inc
May 18, 2015 Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzi... Class II Varian Medical Systems Inc
Nov 5, 2012 Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiat... Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiat... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 17, 2012 Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.... Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned H... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 14, 2012 Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model ... Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can c... Class II Varian Medical Systems, Inc. Oncology Systems
Jul 2, 2012 Varian brand Varian ARIA Oncology Information System, Import Export applicat... A software anomaly has been identified with the Import Export Application version 11.0 where MLC... Class II Varian Medical Systems, Inc. Oncology Systems
Jun 18, 2012 Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model... Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments... Class II Varian Medical Systems, Inc. Oncology Systems

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.