PlainRecalls

Acist Medical Systems

Compiled from official public sources by the publisher.

3 recalls on record · Latest: Mar 10, 2021

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Agency notice ledger

Federal filing book Acist Medical Systems LIGHT-BOOK · SINGLE-AGENCY

#3,304 of 14,151 · 3 notices · 0.003% archive

  • BOOK 3 notices
  • RANK #3,304 of 14,151
  • SHARE 0.003% archive
  • AGENCY FDA Devices (3)
  • CAT medical devices
  • CATS 1 category
  • LATEST Mar 10, 2021
  • PHOTO 3B Medical, Inc.

Nearest notice-volume peer: 3B Medical, Inc. (0 notice gap)

Acist Medical Systems accounts for about 0.003% of the 104,423-notice archive on 3 distinct filings — a light share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Acist Medical Systems's standing among 14,151 recalling firms

Acist Medical Systems ranks 3,304th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Acist Medical Systems vs all firms by recall-notice count

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

3 3304th of 14151 higher than 9,908 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 · 2026-09-16

Acist Medical Systems in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Acist Medical Systems holds about 0.003% of archive notices alongside 3 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Critical Mar 10, 2021

ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
FDA Devices Moderate Feb 10, 2016

ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures
FDA Devices Moderate Apr 24, 2013

ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Acist Medical Systems is a small archive contributor

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

Similar recall count

Nearest multi-notice firms by distinct-event totals (3 here).

3B Medical, Inc. 3 7-Eleven, Inc. 3 A & C Best Food Trading 3 A B Nutrition, Inc. 3 A L I Technologies Ltd 3

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

3B Medical, Inc. 3 A L I Technologies Ltd 3 Abeon Medical Corporation 3 Adria Srl 3

Frequently Asked Questions

How many federal recall notices name Acist Medical Systems? ▼
PlainRecalls indexes 3 distinct federal recall events naming Acist Medical Systems, 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 Acist Medical Systems sit among other recalling firms? ▼
Acist Medical Systems ranks #3,304 of 14,151 by distinct recall-event count among 14,151 firms in this archive (70th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Acist Medical Systems's notices? ▼
FDA Devices accounts for 3 of this firm's 3 indexed notices.
What product category dominates Acist Medical Systems's filing book? ▼
Filings for Acist Medical Systems 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.
Acist Medical Systems: 3 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 Acist Medical Systems; individual notices remain authoritative on each linked recall page.

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