PlainRecalls

Icu Medical, Inc.

Compiled from official public sources by the publisher.

657 recalls on record · Latest: Jul 29, 2026

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Agency notice ledger

Federal filing book Icu Medical, Inc. HEAVY-BOOK · MULTI-AGENCY

#7 of 14,151 · 657 notices · 0.629% archive

  • BOOK 657 notices
  • RANK #7 of 14,151
  • SHARE 0.629% archive
  • AGENCY FDA Devices (640)
  • CAT medical devices
  • CATS 3 categories
  • LATEST Jul 29, 2026
  • PHOTO Newly Weds Foods, Inc.

Nearest notice-volume peer: Newly Weds Foods, Inc. (0 notice gap)

Icu Medical, Inc. sits #7 of 14,151 (7th among 14,151 firms) with 657 federal notices — about 0.629% of the archive (heavy-book tercile). Rank counts issuance frequency, not danger. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Icu Medical, Inc.'s standing among 14,151 recalling firms

Icu Medical, Inc. ranks 7th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Icu Medical, Inc. vs all firms by recall-notice count

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

657 7th of 14151 higher than 14,143 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 · 2026-09-14

Icu Medical, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Icu Medical, Inc. carries 657 distinct federal notices, ranked #7 of 14,151 (heavy-book).

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026

How the 657 notices break down

Same federal filing book as the hero total — split by issuing agency, no new counts.

FDA Devices Moderate Jan 15, 2014

8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
FDA Devices Moderate Jan 15, 2014

10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
FDA Devices Moderate Oct 17, 2012

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Devices Moderate Aug 8, 2012

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Devices Moderate Aug 8, 2012

94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
FDA Devices Moderate Aug 8, 2012

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
FDA Devices Moderate Aug 8, 2012

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

Icu Medical, Inc. sits in the heavy federal notice book

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

Similar medical devices volume

Nearest multi-notice firms that share this firm's dominant product category.

Siemens Healthcare Diagnostics, Inc. 665 Customed, Inc 682 Boston Scientific Corporation 632 Siemens Medical Solutions USA, Inc 796

Frequently Asked Questions

How many federal recall notices name Icu Medical, Inc.? ▼
PlainRecalls indexes 657 distinct federal recall events naming Icu Medical, Inc., 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 Icu Medical, Inc. sit among other recalling firms? ▼
Icu Medical, Inc. ranks #7 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Icu Medical, Inc.'s notices? ▼
FDA Devices accounts for 640 of this firm's 657 indexed notices across 2 issuing agencies.
What product category dominates Icu Medical, Inc.'s filing book? ▼
Filings for Icu Medical, Inc. span 3 product categories, 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.
Icu Medical, Inc.: 657 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 Icu Medical, Inc.; individual notices remain authoritative on each linked recall page.

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