ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Complete recall history across all FDA and CPSC categories — 9 total recalls
ARJOHUNTLEIGH POLSKA Sp. z.o.o. 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 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 29, 2023 | Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... | Unintended movement of bed wheels | Class II |
| Aug 29, 2023 | Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... | Unintended movement of bed wheels | Class II |
| Apr 5, 2022 | Sara Plus Active Floor Lift | The device may emit smoke or ignite. | Class I |
| Jun 10, 2021 | Arjo Citadel beds originally assembled with the IndiGo modules during manufct... | The IndiGo power cord might wear during use which could lead to its damage, r... | Class II |
| Jul 21, 2020 | Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is ... | Modular Junction Box (MJB) cables can melt and affect the bed functionality. | Class II |
| Aug 22, 2019 | Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)050559827... | The firm has become aware that any of the 4 safety catches may exhibit a mech... | Class II |
| Oct 22, 2018 | ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The ... | Inspection process at the manufacturer found nonwoven material was used in sp... | Class II |
| Jun 29, 2016 | ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, r... | ArjoHuntleigh has concluded that a device tipping hazard may occur on the cur... | Class II |
| Jul 28, 2014 | Minstrel (with scale) Product Usage: is a mobile passive hoist. It is inte... | ArjoHuntleigh received three reports where the bolt under the scale unscrewed... | 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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