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 Oct 28, 2020

10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709083346(17)250201(30)50(10)4718652. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062525(17)250101(30)50(10)4558455; (01)10887709062525(17)241201(30)50(10)4537168; (01)10887709062525(17)241201(30)50(10)4493389. The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as conne
FDA Devices Moderate Oct 28, 2020

Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
FDA Devices Moderate Oct 28, 2020

5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
FDA Devices Moderate Oct 28, 2020

9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)10887709090238(17)250101(30)50(10)4572966; (01)10887709090238(17)250101(30)50(10)4557530. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into

FDA Devices Moderate Oct 28, 2020

226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619061231(17)250201(30)50(10)4734990. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Devices Moderate Oct 28, 2020

58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Devices Moderate Oct 28, 2020

60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)250101(30)50(10)4590847; (01)10887709067049(17)250101(30)50(10)4572752; (01)10887709067049(17)250201(30)50(10)4718535; (01)10887709067049(17)250201(30)50(10)4733570. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a con
FDA Devices Moderate Oct 28, 2020

99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066318(17)241201(30)25(10)4537242. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a
FDA Devices Moderate Oct 28, 2020

9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709052953(17)241201(30)50(10)4536611;(01)10887709052953(17)250101(30)50(10)4557492 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle
FDA Devices Moderate Oct 28, 2020

9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50(10)4568886;(01)10887709053004(17)250101(30)50(10)4605109;(01)10887709053004(17)250201(30)50(10)4630689; (01)10887709053004(17)250201(30)50(10)4733556. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a pati
FDA Devices Moderate Oct 28, 2020

NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)10887709058757(17)250101(30)100(10)4590919; (01)10887709058757(17)250201(30)100(10)4712217; (01)10887709058757(17)241201(30)100(10)4537440; (01)10887709058757(17)241201(30)100(10)4549906; (01)10887709058757(17)250101(30)100(10)4559515; (01)10887709058757(17)250201(30)100(10)4719743; (01)10887709058757(17)250201(30)100(10)4726897; (01)10887709058757(17)250201(30)1
FDA Devices Moderate Oct 28, 2020

20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(17)250401(30)50(10)4803158; (01)10887709069203(17)250101(30)50(10)4558617; (01)10887709069203(17)250101(30)50(10)4589967. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system thro
FDA Devices Moderate Oct 28, 2020

78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
FDA Devices Moderate Oct 28, 2020

11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709069524(17)250201(30)50(10)4711196. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709077758(17)250101(30)50(10)4603285;(01)10887709077758(17)250101(30)50(10)4603285; (01)10887709077758(17)250101(30)50(10)4630700; (01)10887709077758(17)250301(30)50(10)4749870; (01)10887709077758(17)241201(30)50(10)4514843; (01)10887709077758(17)241201(30)50(10)4549093; (01)10887709077758(17)250101(30)50(10)4558478; (01)10887709077758(17)250201(30)50(10)
FDA Devices Moderate Oct 28, 2020

6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)250101(30)50(10)4573963; (01)10887709087719(17)241201(30)50(10)4515215. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is
FDA Devices Moderate Oct 28, 2020

6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)10887709079877(17)250101(30)50(10)4559022. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30)50(10)4557524. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709052816(17)241201(30)50(10)4537141 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inse
FDA Devices Moderate Oct 28, 2020

22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10887709051967(17)250201(30)50(10)4727498. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UDI:(01)10840619076174(17)250201(30)50(10)4735112; (01)10840619076174(17)241201(30)50(10)4493240. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Devices Moderate Oct 28, 2020

9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)50(10)4603290. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case. UDI:(01)10887709088190(17)241201(30)50(10)4515232;(01)10887709068350(17)250101(30)50(10)4572761 The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathw
FDA Devices Moderate Oct 28, 2020

7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(01)10887709065069(17)250201(30)50(10)4733564. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250101(30)50(10)4584874; (01)10840619092754(17)250101(30)50(10)4565685 Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Devices Moderate Oct 28, 2020

149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;(01)10887709074696(17)250201(30)25(10)4719610. . The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a ve
FDA Devices Moderate Oct 28, 2020

40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50(10)4603496. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709075501(17)250101(30)50(10)4558474. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460; (01)10887709095298(17)250101(30)25(10)4589956; (01)10887709095298(17)250201(30)25(10)4711185. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration se
FDA Devices Moderate Oct 28, 2020

NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111; (01)10840619060906(17)241201(30)100(10)4493213; (01)10840619060906(17)241201(30)100(10)4510900; (01)10840619060906(17)250301(30)100(10)4749152. Administration sets and their accessories are single use, pre-sterilized devices that provide acc
FDA Devices Moderate Oct 28, 2020

12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265; (01)10887709087526(17)250201(30)50(10)4724859; (01)10887709087526(17)250201(30)50(10)4734417. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the admin
FDA Devices Moderate Oct 28, 2020

165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)241201(30)50(10)4553703. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Devices Moderate Oct 28, 2020

120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040141(17)250101(30)25(10)4573652. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set.
FDA Devices Moderate Oct 28, 2020

139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121147(17)250101(30)25(10)4556713; (01)10887709121147(17)250101(30)25(10)4603383; (01)10887709121147(17)250101(30)25(10)4573356. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular syst
FDA Devices Moderate Oct 28, 2020

9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265. The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.
FDA Devices Moderate Oct 28, 2020

8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. .
FDA Devices Moderate Oct 28, 2020

11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; (01)10840619059801(17)241201(30)50(10)4514500; (01)10840619059801(17)250201(30)50(10)4727354. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted in
FDA Devices Moderate Oct 28, 2020

3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50(10)4579939; (01)10887709087153(17)250101(30)50(10)4592179; (01)10887709087153(17)250101(30)50(10)4610925; (01)10887709087153(17)241201(30)50(10)4547212; (01)10887709087153(17)250101(30)50(10)4712946; (01)10887709087153(17)250201(30)50(10)4720392. The Intravascular Administration Set is a single use, sterile,
FDA Devices Moderate Oct 28, 2020

8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(10)4717491. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Devices Moderate Oct 28, 2020

9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)4558471. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Devices Moderate Oct 28, 2020

2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)4536673. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless ac
FDA Devices Moderate Oct 28, 2020

NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery.
FDA Devices Moderate Oct 28, 2020

135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Devices Moderate Oct 28, 2020

7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10840619066014(17)250201(30)50(10)4718521;(01)10840619066014(17)250201(30)50(10)4735100. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted int
FDA Devices Moderate Oct 28, 2020

8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709075334(17)250101(30)50(10)4572784. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

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