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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Feb 23, 2024 The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... Class II Magellan Diagnostics, Inc.
Sep 19, 2023 LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test ki... During an internal audit a small percentage (<10%) of plastic caps used to close the treatment re... Class II Magellan Diagnostics, Inc.
May 7, 2021 LeadCare II Blood Lead Test Kit Catalog Number 70-6762 Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... Class I Magellan Diagnostics, Inc.
May 7, 2021 LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... Class I Magellan Diagnostics, Inc.
May 7, 2021 LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... Class I Magellan Diagnostics, Inc.
Aug 8, 2018 Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement ... Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values... Class II Magellan Diagnostics, Inc.
Jan 9, 2018 LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the q... The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause ... Class II Magellan Diagnostics, Inc.
Jan 9, 2018 LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P,... The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause th... Class II Magellan Diagnostics, Inc.
May 23, 2017 Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product U... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, Inc.
May 23, 2017 Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: ... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, Inc.
Jan 20, 2016 LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Prod... LeadCare II Test Kits controls out of range Class II Magellan Diagnostics, Inc.
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... Class I Magellan Diagnostics, Inc.
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... Class I Magellan Diagnostics, 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.