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Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
May 7, 2025 Z-800F Infusion System. Intended to provide intravenous infusion of parentera... Unreleased software versions were installed on distributed devices without verification or valida... Class I Zyno Medical LLC
May 7, 2025 Z-800W Infusion System. Intended to provide intravenous infusion of parentera... Unreleased software versions were installed on distributed devices without verification or valida... Class I Zyno Medical LLC
May 7, 2025 Z-800WF Infusion System. Intended to provide intravenous infusion of parenter... Unreleased software versions were installed on distributed devices without verification or valida... Class I Zyno Medical LLC
May 7, 2025 Z-800 Infusion System. Intended to provide intravenous infusion of parenteral... Unreleased software versions were installed on distributed devices without verification or valida... Class I Zyno Medical LLC
Oct 18, 2024 Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. ... Potential for the battery to deplete over time from self-discharge and internal parasitic leakage... Class II Zyno Medical LLC
Sep 30, 2024 Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Numbe... For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been ... Class III Zyno Medical LLC
Sep 13, 2024 Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Softwar... There is a defect in the air-in-line software algorithm. Class I Zyno Medical LLC
Jun 4, 2024 Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply... Class II Zyno Medical LLC
Dec 20, 2023 Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5... Class II Zyno Medical LLC
May 29, 2019 Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For... Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of th... Class II Zyno Medical LLC
May 29, 2019 Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- Fo... Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of th... Class II Zyno Medical LLC
Jul 29, 2016 Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... Administration Set potential filter leaking Class II Zyno Medical LLC
Jul 29, 2016 Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infus... Administration Set potential filter leaking Class II Zyno Medical LLC
Jul 29, 2016 Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusi... Administration Set potential filter leaking Class II Zyno Medical LLC
Jul 29, 2016 Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... Administration Set potential filter leaking Class II Zyno Medical LLC
Jun 13, 2011 Z-800 Volumetric Infusion System. For intravenous infusion of parenteral f... Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer so... Class II Zyno Medical 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.