PlainRecalls

Icu Medical, Inc.

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 Jul 29, 2026

Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70

FDA Devices Moderate Jul 22, 2026

ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump

FDA Devices Moderate Jul 22, 2026

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

FDA Devices Moderate Jun 17, 2026

Plum Duo Precision IV Pump, 40002-0403

FDA Devices Moderate Jun 17, 2026

Plum Duo Infusion Pump, 40002-0401

FDA Devices Moderate Jun 17, 2026

Plum Solo Precision IV Pump, 40001-0401

FDA Devices Moderate May 27, 2026

Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

FDA Devices Moderate Jan 28, 2026

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

FDA Devices Moderate Jan 28, 2026

Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

FDA Devices Moderate Jan 28, 2026

ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

FDA Devices Moderate Jan 28, 2026

ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

FDA Devices Moderate Jan 21, 2026

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

FDA Devices Moderate Jan 21, 2026

Portex Spinal Tray, Item No. A3729-24 A3595

FDA Devices Moderate Jan 21, 2026

Plum Duo Infusion System, List Number 40002-04-01

FDA Devices Moderate Dec 31, 2025

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

FDA Devices Moderate Dec 31, 2025

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemosafeLock Connecter REF: KL-FNU3

FDA Devices Moderate Nov 5, 2025

ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

FDA Devices Moderate Nov 5, 2025

ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

FDA Devices Moderate Nov 5, 2025

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

FDA Devices Moderate Nov 5, 2025

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

FDA Devices Moderate Nov 5, 2025

ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

FDA Devices Moderate Nov 5, 2025

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

FDA Devices Moderate Nov 5, 2025

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

FDA Devices Moderate Nov 5, 2025

ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Port REF: CL2100

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188

FDA Devices Moderate Nov 5, 2025

ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

FDA Devices Moderate Nov 5, 2025

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Bag Spike REF: CL-10

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Closed Vial Spike REF: CL-80

FDA Devices Moderate Nov 5, 2025

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

FDA Devices Moderate Nov 5, 2025

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

FDA Devices Moderate Nov 5, 2025

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

FDA Devices Moderate Nov 5, 2025

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929

FDA Devices Moderate Nov 5, 2025

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

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.

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