Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 1, 2010 | Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood... | Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 12, 2010 | Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: ... | Software Version 3.1.1 does not meet navigational accuracy. | Class II | Medtronic Navigation, Inc. |
| Jan 6, 2010 | ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.3... | The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80... | Class II | Sendx Medical Inc |
| Nov 10, 2009 | Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: ... | Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. T... | Class II | Olympus America Inc. |
| Apr 13, 2009 | Sunquest Encompass The reporting site is using the Encompass software in a... | Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect ... | Class III | Sunquest Information Systems, Inc. |
| Apr 6, 2009 | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring ... | The firm is initiating this recall because the implied or stated indications in their labeling as... | Class II | Stellate Systems |
| Oct 28, 2008 | Navitrack System - OS Knee Universal, Stereotaxic instrument | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Aug 28, 2008 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 36... | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control M... | Class II | Sechrist Industries Inc |
| Aug 28, 2008 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 33... | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control M... | Class II | Sechrist Industries Inc |
| Jun 20, 2008 | Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... | Class III | Orthosoft, Inc. dba Zimmer CAS |
| Jun 4, 2008 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is u... | Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk o... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Sep 15, 2006 | InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing... | Please be aware that this is not a new recall. The firm has taken action; but, due to administra... | Class I | GE OEC Medical Systems, Inc |
| Apr 25, 2006 | Brilliance CT (computed tomography) scanners, Big Bore configuration, Model n... | Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization appli... | Class II | Philips Medical Systems (Cleveland) 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.