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Dexcom Inc

Complete recall history across all FDA and CPSC categories — 11 total recalls

Dexcom Inc 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 (11)

FDA medical device enforcement actions by Dexcom Inc

Date Product Reason Class
Feb 3, 2020 Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... The company identified potential interference from hydroxyurea. Patient use o... Class II
Feb 3, 2020 Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLAT... The company identified potential interference from hydroxyurea. Patient use o... Class II
Feb 3, 2020 Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... The company identified potential interference from hydroxyurea. Patient use o... Class II
Nov 19, 2019 Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Ver... It was reported that the user's low alarm feature on the iOS application were... Class II
Jul 12, 2019 Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing softw... It has been reported that use of the mobile receiver with software version SW... Class II
Feb 23, 2016 Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receive... Customers may not receive an intended audible alarm or alert if relying on he... Class I
Feb 23, 2016 Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT2... Customers may not receive an intended audible alarm or alert if relying on he... Class I
Feb 23, 2016 Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Bl... Customers may not receive an intended audible alarm or alert if relying on he... Class I
Feb 23, 2016 Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), ... Customers may not receive an intended audible alarm or alert if relying on he... Class I
Feb 23, 2016 Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiv... Customers may not receive an intended audible alarm or alert if relying on he... Class I
Feb 23, 2016 Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Rec... Customers may not receive an intended audible alarm or alert if relying on he... Class I

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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