Browse Device Recalls
4 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4 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 4 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 12, 2017 | MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Produ... | Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet produc... | Class II | Mesa Laboratories, Inc. |
| Sep 13, 2013 | pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints ... | Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth. | Class II | Mesa Laboratories, Inc. |
| Jun 4, 2013 | Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in d... | Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently deter... | Class II | Mesa Laboratories, Inc., Bozeman Manufacturing ... |
| Jun 4, 2013 | Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended fo... | Self-contained steam biological indicator, are recalled because Mesa recently determined that the... | Class II | Mesa Laboratories, Inc., Bozeman Manufacturing ... |
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.