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ICU Medical, Inc.

ICU Medical, Inc. Recalls

All product recalls associated with ICU Medical, Inc..

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Recall Summary

Total Recalls

1000

Past Year

579

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 7681–7700 of 10937 recalls

ICU Medical, Inc.: Port Access Kit with MicroClave Clear Connector, Item No....

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: Cap Change Kit with MicroClave Clear Connector, Item No. ...

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: CAP Change Kit w/MicroClave Clear, Item No. B78109 BD ...

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

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Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

Medical Components, Inc dba MedComp: Split Cath III Trays, 16F x 28CM Product Usage: The...

The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.

Class IIModerate

FDAAug 4, 2014Nationwide• Medical Components, Inc dba MedComp

Civco Medical Instruments Inc: CollectEVAC, Sterile device with tubing and adaptor for u...

A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

Class IIModerate

FDAAug 1, 2014AZ, IL, LA +13 more• Civco Medical Instruments Inc

Mindray DS USA, Inc. dba Mindray North America: Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, ...

Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.

Class IIModerate

FDAJul 31, 2014Nationwide• Mindray DS USA, Inc. dba Mindray North America

Philips Electronics North America Corporation: Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model ...

Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.

Class IIModerate

FDAJul 31, 2014Nationwide• Philips Electronics North America Corporation

Philips Medical Systems, Inc.: Philips Brilliance iCT Computed Tomography X-Ray System ...

It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

Class IIModerate

FDAJul 31, 2014Nationwide• Philips Medical Systems, Inc.

Rx CHOICE Liquid Vitamin C (Hi-Tech) – pH Specification Issue (2014)

Out-of-specification results for pH.

Class IIILow

FDAJul 28, 2014CA, FL, ID +13 more• Hi-Tech Pharmacal Co., Inc.

Philips Medical Systems (Cleveland) Inc: IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (...

The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (

Class IIModerate

FDAJul 27, 2014AL, AK, AZ +34 more• Philips Medical Systems (Cleveland) Inc

Raw Carob Powder (Glaser Organic) – contamination risk (2014)

Salmonella

Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination.

Class IHigh

FDAJul 24, 2014FL, GA, IL +4 more• Glaser Organic Farms

Ham & Cheddar Sandwich (Great American Marketing) – listeria risk (2014)

Listeria

The product has the potential to be contaminated with Listeria monocytogenes.

Class IHigh

FDAJul 24, 2014IN, TX• Great American Marketing Company

Carob Coconut Raspberry Fruit Pie (Glaser Organic) – potential health risk (2014)

Salmonella

Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination.

Class IHigh

FDAJul 24, 2014FL, GA, IL +4 more• Glaser Organic Farms

Philips Healthcare Informatics, Inc.: Philips IntelliSpace PACS 4.4 image management systems pe...

A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.

Class IIModerate

FDAJul 24, 2014Nationwide• Philips Healthcare Informatics, Inc.

Carob Fudgy Brownie (Glaser Organic) – potential health risk (2014)

Salmonella

Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination.

Class IHigh

FDAJul 24, 2014FL, GA, IL +4 more• Glaser Organic Farms

Turkey & Swiss Sandwich (Great American Marketing) – listeria risk (2014)

Listeria

The product has the potential to be contaminated with Listeria monocytogenes.

Class IHigh

FDAJul 24, 2014IN, TX• Great American Marketing Company

Raw Vegan Carob Pudding Pie (Glaser Organic) – contamination risk (2014)

Salmonella

Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination.

Class IHigh

FDAJul 24, 2014FL, GA, IL +4 more• Glaser Organic Farms

Epel Estradiol Pellet (Physician Preferred) – non-sterile (2014)

Non-Sterility: The recalled lot failed sterility testing.

Class IHigh

FDAJul 24, 2014AZ, KS• Physician Preferred Medical, LLC

Becton Dickinson & Company: BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride ...

BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).

Class IIModerate

FDAJul 22, 2014Nationwide• Becton Dickinson & Company

GF Health Products, Inc./d.b.a.Basic American Metal Products: Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS9867...

The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended.

Class IIModerate

FDAJul 21, 2014Nationwide• GF Health Products, Inc./d.b.a.Basic American Metal Products