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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jul 4, 2022 Medicina Reusable Oral syringe 1ml Code: OTH01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Reusable Oral syringe 2.5ml Code: OTH25 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Oral Tip Syringe 1ml Code: OT01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Reusable Oral syringe 5ml Code: OTH05 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Oral Tip Syringe 2.5ml Code: OT25 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Oral Tip Syringe 0.5ml Code: OT005 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk 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.