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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Jun 4, 2018 EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofu... Mislabeled product Class III Richard-Allan Scientific Company
Mar 15, 2017 Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome... Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead. Class II Richard-Allan Scientific Company
Jun 13, 2016 Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 a... potential contamination with potassium hydroxide may have an impact when performing immunohistoch... Class II Richard-Allan Scientific Company
Feb 16, 2016 Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For us... Multiple complaints were received from customers indicating that they ordered product 8335(Type 3... Class III Richard-Allan Scientific Company
Apr 29, 2015 Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquef... Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a... Class II Richard-Allan Scientific Company
Apr 29, 2015 Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Muco... Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a... Class II Richard-Allan Scientific Company
Feb 19, 2015 Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon... The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as... Class III Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Specimen Transportation System. 10% NBF is used t... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% ... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Specimen Transportation System. Product Usage: 10... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is ... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company

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.