Browse Device Recalls
9 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 9 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 9 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 28, 2012 | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack.... | Mindray has identified a software anomaly that may where, in the presence of an asystole, the Tel... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Nov 28, 2012 | BS-200 Chemistry Analyzer Designed for clinical laboratory use. | An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Sep 24, 2012 | Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manuf... | Mindray has identified an issue with the V Series Monitor where the monitors touch screen may sto... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Sep 5, 2012 | Mindray DPM5 Monitor, a vital signs monitor used on human patients in health... | Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not b... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Aug 13, 2012 | Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS ... | Mindray has identified the potential for a system leak resulting an issue related to the carbon d... | Class I | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Aug 13, 2012 | Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS ... | Mindray has identified the potential for a system leak resulting an issue related to the carbon d... | Class I | Mindray DS USA, Inc. d.b.a. Mindray North America |
| May 7, 2012 | V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Seri... | Mindray has identified two software anomalies contained in the V Series Monitoring System. There... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| May 12, 2011 | DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ... | There is a software anomaly with the DPM Central Monitoring System where the trend data of one pa... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Aug 11, 2010 | DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. ... | There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailab... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
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.