Bard Medical Division
Complete recall history across all FDA and CPSC categories — 5 total recalls
Bard Medical Division 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 Bard Medical Division
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 13, 2018 | SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Produc... | potential for urine leakage around the vent on the vented sample port | Class II |
| Dec 6, 2018 | BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing... | Some SureStep" Foley Tray Systems with product catalog number A319418AM and l... | Class II |
| Jun 13, 2018 | Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 500... | An improper wiring connection on the chiller assembly may result in overheati... | Class II |
| Mar 21, 2018 | Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Pro... | Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were... | Class II |
| Nov 8, 2017 | Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number ... | Specific lots of ArcticGel Pads have potential issues which may result in the... | 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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