All Recalls

95,025 total recalls in our database

Foundation Kit

Stradis Medical, LLC

🏥 Medical Devices Class I - Dangerous

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Sep 10, 2021 Other Medical Devices Nationwide View Details →

Due to misbranded products shipped to customers.

Aug 24, 2021 Surgical Instruments View Details →

IUD Insertion Pack

Stradis Medical, LLC

🏥 Medical Devices Class I - Dangerous

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Sep 10, 2021 Other Medical Devices Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

Sep 20, 2021 Other Medical Devices Nationwide View Details →

Due to misbranded products shipped to customers.

Aug 24, 2021 Surgical Instruments View Details →

IUD Insertion Kit

Stradis Medical, LLC

🏥 Medical Devices Class I - Dangerous

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Sep 10, 2021 Other Medical Devices Nationwide View Details →

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

Sep 21, 2021 Infusion Pumps Nationwide View Details →

Atellica IM 1600 Analyzer, SMN 11066000

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

Sep 28, 2021 Other Medical Devices Nationwide View Details →