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Boston Scientific

Complete recall history across all FDA and CPSC categories — 12 total recalls

Boston Scientific appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (12)

FDA medical device enforcement actions by Boston Scientific

Date Product Reason Class
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M00617527208... An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M00617526... An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M00667... An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00... An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M00667030... An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006... An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 An increase in the rate of complaints for difficulty or inability to track ov... Class II
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 An increase in the rate of complaints for difficulty or inability to track ov... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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