Browse Device Recalls
110 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 110 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 110 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 23, 2017 | JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G ... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Jul 1, 2016 | DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ... | BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou... | Class I | Carefusion 2200 Inc |
| Jun 29, 2016 | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored... | The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... | Class II | Carefusion 2200 Inc |
| Jun 29, 2016 | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module ... | The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... | Class II | Carefusion 2200 Inc |
| Jul 31, 2014 | CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respira... | The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory comp... | Class II | Carefusion 2200 Inc |
| Aug 28, 2013 | *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareF... | Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, p... | Class II | Carefusion 2200 Inc |
| Apr 22, 2013 | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) ... | CareFusion has received four (4) customer reports of a component (oxygen connector) within the re... | Class II | Carefusion 2200 Inc |
| May 29, 2012 | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an ... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| May 29, 2012 | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated;... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| May 29, 2012 | AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; ... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 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.