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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 13, 2022 ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number S... MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case ... Class II Materialise USA LLC
May 3, 2016 Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instru... A patient specific case of Signature Personalized Patient Care System Knee Guides included a femu... Class II Materialise USA LLC
Oct 16, 2014 Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is... The box of guides for a specific case arrived intact but contained two (2) femoral guides instead... Class II Materialise USA LLC
Nov 26, 2013 REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M... Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. Class II Materialise USA LLC
Nov 8, 2013 ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : ... Patient Specific Guide contained the incorrect case report. The case report contains patient spe... Class II Materialise USA LLC
Nov 8, 2013 ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : ... Patient Specific Guide contained the incorrect case report. The case report contains patient spe... Class II Materialise USA LLC

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.