Balt Usa, Llc
Complete recall history across all FDA and CPSC categories — 8 total recalls
Balt Usa, Llc 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 (8)
FDA medical device enforcement actions by Balt Usa, Llc
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 25, 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... | Due to an identified manufacturing defect involving coating material lifting ... | Class I |
| May 8, 2025 | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BL... | Due to radiopaque (RO) marker was not visible during angiography and it was d... | Class II |
| May 8, 2025 | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1... | Due to radiopaque (RO) marker was not visible during angiography and it was d... | Class II |
| Jan 3, 2024 | The Prestige Coil System is a product family of embolic coils with associated... | Discoloration was identified along the delivery pusher which was attributed t... | Class II |
| Jan 3, 2024 | Neurovascular embolization device. The Optima Coil System is a series special... | Discoloration was identified along the delivery pusher which was attributed t... | Class II |
| Sep 7, 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308... | Product pouch label does not match up with carton label | Class II |
| Jul 26, 2022 | Optima Coil System Model OPTI0520CSF10. For endovascular embolization. | Products were released to customers prior to the approval and release of a te... | Class II |
| Jan 4, 2022 | The Optima Coil System consists of an implantable embolization coil comprised... | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf cart... | 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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