Browse Device Recalls
19 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 19 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 19 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 12, 2019 | Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks,... | Gas springs not always replaced within the interval specified. | Class II | Tecan US, Inc. |
| Jul 23, 2018 | Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On ... | There is a software issue that can potentially impact sample identification and traceability unde... | Class II | Tecan US, Inc. |
| Jan 12, 2018 | Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol S... | Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1... | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate ... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader fo... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochrom... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional m... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance read... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 20... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infini... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| Nov 10, 2014 | Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Tecan US, Inc. |
| Nov 10, 2014 | Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Tecan US, Inc. |
| Sep 26, 2014 | Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open... | Distortion (noise interference) of the liquid level capacitance can result in air aspiration inst... | Class II | Tecan US, Inc. |
| Feb 19, 2013 | Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of ... | WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock... | Class II | Tecan US, 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.