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Recalls, Market Withdrawals, & Safety Alerts

 

The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.

The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

Date Brand Name(s) Product Description Product Type Recall Reason Description Company Name Terminated Recall Excerpt
BD ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators Drugs Potential fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides BD … BD … BD … FRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ …
BD Alaris BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets Medical Devices Pump performance variations compared to the performance described in the user manual could impact infusion delivery BD … BD Alaris … BD … FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology …
Alaris™ and BD Alaris™ Pump Modules Medical Devices May have been serviced with previously recalled bezel kit assemblies Becton, Dickinson and Company … Alaris™ and BD Alaris™ … Becton, Dickinson and Company … FRANKLIN LAKES, N.J. (July 15, 2025) – BD (Becton, …
BD ChloraPrep Clear 1 mL applicator skin preparation product Drugs Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides BD … BD … BD … FRANKLIN LAKES, N.J. (Feb. 15, 2025) – BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of …
Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels Medical Devices Potentially weakened plastic Tenacore LLC Terminated … of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be … bezel nationwide. Consumers with questions may contact the company via telephone at provide 1-800-297-2241 between the …
Alaris Alaris Infusion Pump Medical Devices Hardware issues may cause the infusion pump to not operate as expected Becton, Dickinson and Company Terminated … Alaris … Becton, Dickinson and Company … Majority of June 30 Recall Designated as Class I Recall by FDA BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global …
Alaris Alaris Pump Module Model 8100 and Certain Alaris Pump Infusion Sets Medical Devices Weakening of the plastic can lead to damage or separation of the bezel posts which can cause issues with infusion, or unintended delivery of medication when pump module is not in running status BD Terminated … Alaris … BD … BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology …
BD Vacutainer tubes Drugs Inaccurate lead test results BD … BD … BD … BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it is updating the instructions for …
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