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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Mar 22, 2012 Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit,... The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain Syringing Pipettes 240 (Catalog #490517) The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Dec 8, 2011 PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.
Dec 8, 2011 PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a li... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.
Dec 8, 2011 PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin ... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.
Dec 8, 2011 PrepStain Slide Processor. The PrepStain System is a liquid-based thin lay... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.

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.