Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Apr 5, 2024 IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fab... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
Apr 5, 2024 IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabr... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
Apr 5, 2024 IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabr... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
Apr 5, 2024 IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fab... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
Apr 5, 2024 IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabr... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
Apr 5, 2024 IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabr... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental u... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental ... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG

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.