Arjo, Inc. dba ArjoHuntleigh

Complete recall history across all FDA and CPSC categories — 9 total recalls

Arjo, Inc. dba ArjoHuntleigh 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 (9)

FDA medical device enforcement actions by Arjo, Inc. dba ArjoHuntleigh

Date Product Reason Class
Jun 14, 2017 ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used ... Reports of the device failure involving delivering continuous pressure to the... Class II
Dec 21, 2015 The Concerto Basic Shower Trolley is intended for assisted hygiene care, espe... Reports of the bolts connecting the stretcher to the hydraulic piston and the... Class II
Jan 21, 2013 Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and... The upper portion of the hooks on the spreader bar are too flexible for holdi... Class II
Dec 10, 2012 Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein th... The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. Class II
Nov 16, 2012 Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in elec... ArjoHuntleigh has received reports of unintended movement where the backrest ... Class II
Nov 16, 2012 Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB,... ArjoHuntleigh has received reports of unintended movement where the backrest ... Class II
Jun 29, 2012 Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning in... Class II
Jun 29, 2012 Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Prod... ArjoHuntleigh has received a limited number of customer reports concerning in... Class II
Jun 29, 2012 Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning in... 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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