DeVilbiss Healthcare LLC

Complete recall history across all FDA and CPSC categories — 6 total recalls

DeVilbiss Healthcare LLC 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 (6)

FDA medical device enforcement actions by DeVilbiss Healthcare LLC

Date Product Reason Class
Mar 9, 2023 DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1... The instruction manual is being replaced with an updated version that is in a... Class II
Nov 18, 2022 DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q The firm has received complaints of the device becoming hot. The firm has upd... Class II
Sep 19, 2022 125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio... An unapproved adhesive used to manufacture the accumulator tank sub assembly ... Class II
May 23, 2016 DeVilbiss Model 7305P-D Powered Suction Unit A small percentage of units of 7305 Series Vacu-Aide Suction Units are experi... Class II
May 13, 2014 DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep... A limited number of DV5x Series CPAP units were manufactured and shipped with... Class III
Mar 7, 2013 DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 8... End users of the DeVilbiss Disposable Suction Container/Filter had exposed th... 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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