PlainRecalls

B-k Medical A/s

Compiled from official public sources by the publisher.

9 recalls on record · Latest: Nov 12, 2025

Subscribe to new B-k Medical A/s recalls (RSS)

Agency notice ledger

Federal filing book B-k Medical A/s LIGHT-BOOK · SINGLE-AGENCY

#1,561 of 14,151 · 9 notices · 0.009% archive

  • BOOK 9 notices
  • RANK #1,561 of 14,151
  • SHARE 0.009% archive
  • AGENCY FDA Devices (9)
  • CAT medical devices
  • CATS 1 category
  • LATEST Nov 12, 2025
  • PHOTO 3Cs Organics LLC

Nearest notice-volume peer: 3Cs Organics LLC (0 notice gap)

B-k Medical A/s accounts for about 0.009% of the 104,423-notice archive on 9 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How B-k Medical A/s compares to 14,151 recalling firms

B-k Medical A/s ranks 1,561st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

B-k Medical A/s vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

9 1561st of 14151 higher than 12,464 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

B-k Medical A/s in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows B-k Medical A/s holds about 0.009% of archive notices alongside 9 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Nov 12, 2025

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Devices Moderate Nov 12, 2025

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Devices Moderate Nov 12, 2025

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Devices Moderate Nov 12, 2025

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Devices Moderate Nov 12, 2025

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Devices Moderate Nov 12, 2025

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Devices Moderate Oct 30, 2024

bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
FDA Devices Moderate Jan 31, 2024

bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
FDA Devices Moderate Aug 10, 2016

BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

B-k Medical A/s holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name B-k Medical A/s? ▼
PlainRecalls indexes 9 distinct federal recall events naming B-k Medical A/s, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does B-k Medical A/s sit among other recalling firms? ▼
B-k Medical A/s ranks #1,561 of 14,151 by distinct recall-event count among 14,151 firms in this archive (88th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of B-k Medical A/s's notices? ▼
FDA Devices accounts for 9 of this firm's 9 indexed notices.
What product category dominates B-k Medical A/s's filing book? ▼
Filings for B-k Medical A/s span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
B-k Medical A/s: 9 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming B-k Medical A/s; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026