Product Safety Recalls

Product Recall Tracker

Stradis Medical, LLC dba Stradis Healthcare Recall 88656

Description: Foundation Kit

Stradis Medical, LLC dba Stradis Healthcare Recall 88656 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0130-2022
Event ID88656
Event DescriptionFoundation Kit
Product TypeDevices
DistributionDistributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
Quantity790 kits
Recall ReasonFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Device Classification20211027
Device Code InfoPart Number: A10
Center Classification Date20211016
Recall Initiation Date20210910
Recalling FirmStradis Medical, LLC dba Stradis Healthcare
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.