Arrow International, Inc., Division of Teleflex Medical Inc.
Complete recall history across all FDA and CPSC categories — 9 total recalls
Arrow International, Inc., Division of Teleflex Medical Inc. 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 Arrow International, Inc., Division of Teleflex Medical Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ I... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is util... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aort... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation o... | Class I |
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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