Browse Device Recalls
709 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 709 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 709 FDA device recalls in CT.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 9, 2012 | Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mam... | Digital Skin Mammography Marker separating from the backing of the spot material | Class II | Beekley Corporation |
| Jul 9, 2012 | Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: desig... | Digital Skin Mammography Marker separating from the backing of the spot material | Class II | Beekley Corporation |
| Jul 2, 2012 | Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30c... | Imaging artifact can occur on mammogram result | Class II | Beekley Corporation |
| Jun 29, 2012 | MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporat... | The MXR-35 X-ray Generator's labeling did not include the certification statement as required by ... | Class II | Fujifilm Medical System USA, Inc. |
| May 9, 2012 | Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA T... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA ... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA ... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA T... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA ... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
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.