Bioseal Corporation
Complete recall history across all FDA and CPSC categories — 5 total recalls
Bioseal Corporation 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 Bioseal Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 23, 2021 | Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, RE... | Pre-op skin prep component ChloraPrep included within kits may allow the grow... | Class II |
| Mar 23, 2021 | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... | Pre-op skin prep component ChloraPrep included within kits may allow the grow... | Class II |
| Mar 23, 2021 | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... | Pre-op skin prep component ChloraPrep included within kits may allow the grow... | Class II |
| Aug 15, 2019 | Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, S... | The reported stress crack in the port of the swivel elbow where the flip cap ... | Class II |
| Oct 18, 2017 | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were s... | 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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