Boston Scientific Corporation: FDA recalls

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Share of the events of the firm in Class I

14%

Share of all events on the register in Class I

18%

Events with the status Ongoing

83

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

• FDA enforcement reportsThe FDA search of the weekly enforcement reports.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA: report a problemThe FDA page that shows where a report about a product goes.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Which classes do the FDA recalls of Boston Scientific Corporation have?

Class II: 136 events. Class I: 22 events. Class III: 4 events. The class is for the product of a recall. It is not a class of the firm.

What is the newest FDA recall of Boston Scientific Corporation?

FDA event 99524, which the firm started on 6 Aug 2026. The first product in the record is: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)

How many FDA recalls of Boston Scientific Corporation have the status Ongoing?

83 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.