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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.

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DateProductReasonClassFirm
Jul 29, 2020 Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only... LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce... Class II Sorin Group Italia S.r.l.
Jul 29, 2020 Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only... LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce... Class II Sorin Group Italia S.r.l.
Jul 29, 2020 Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, U... LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce... Class II Sorin Group Italia S.r.l.
Jul 29, 2020 Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only,... LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce... Class II Sorin Group Italia S.r.l.
Jul 29, 2020 Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only,... LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce... Class II Sorin Group Italia S.r.l.
Nov 20, 2013 ORCHESTRA/ORCHESTRA PLUS Programmer Sorin has voluntarily issued a notification to physicians related to the overestimation of the re... Class II Sorin Group Italia S.r.l.

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.