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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 19, 2024 TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-bas... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-base... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-base... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD

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.