B-K Medical A/S
Complete recall history across all FDA and CPSC categories — 9 total recalls
B-K Medical A/S 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 B-K Medical A/S
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 9, 2025 | bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user ... | Class II |
| Oct 9, 2025 | bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user ... | Class II |
| Oct 9, 2025 | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: ... | GE HealthCare has become aware that the Instructions for Use within the user ... | Class II |
| Oct 9, 2025 | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imagin... | GE HealthCare has become aware that the Instructions for Use within the user ... | Class II |
| Oct 9, 2025 | bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user ... | Class II |
| Oct 9, 2025 | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; Sys... | GE HealthCare has become aware that the Instructions for Use within the user ... | Class II |
| Sep 4, 2024 | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and b... | The internal power connections at the power inlet of the ultrasound devices c... | Class II |
| Nov 30, 2023 | bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. | An issue on the Dual Live Compare feature on the bkActiv system could result ... | Class II |
| Jun 28, 2016 | BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with softw... | In the system (bk3500) software generic volume measurement (HxWxLxl) function... | 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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