Devicor Medical Products Inc

Complete recall history across all FDA and CPSC categories — 4 total recalls

Devicor Medical Products 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 (4)

FDA medical device enforcement actions by Devicor Medical Products Inc

Date Product Reason Class
Mar 30, 2022 HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 Small patient labels do not match the primary device label. The primary devic... Class II
Sep 7, 2020 Neoprobe GDS Control Unit, Model Number NPCU3 It was discovered during a documentation review that China has the software v... Class III
Feb 28, 2017 Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to s... The device did not have Revolve Stereo Probe labeling, no product code indica... Class II
May 19, 2016 Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MS... A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. 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.

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