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Arjo Hospital Equipment AB

Complete recall history across all FDA and CPSC categories — 5 total recalls

Arjo Hospital Equipment AB 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 (5)

FDA medical device enforcement actions by Arjo Hospital Equipment AB

Date Product Reason Class
Dec 3, 2014 Rotoprone Therapy System. The Rotoprone Therapy System is an advanced pati... The recalled devices labeling and instructions for use contain unapproved med... Class II
Dec 3, 2014 RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kineti... The recalled devices labeling and instructions for use contain unapproved med... Class II
Dec 3, 2014 TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Crit... The recalled devices labeling and instructions for use contain unapproved med... Class II
Sep 1, 2014 Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Inte... The firm received complaints regarding multiple mattresses were showing failu... Class II
Mar 17, 2014 ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients... There is a low but existing entrapment risk for a patient being treated on 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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