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GE Medical Systems, LLC

GE Medical Systems, LLC Recalls

All product recalls associated with GE Medical Systems, LLC.

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Recall Summary

Total Recalls

1000

Past Year

581

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 2041–2060 of 10937 recalls

Vivid S6 N Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Conzerol Molluscum Treatment (Discovery Pharma) – CGMP Deviation (2022)

CGMP deviations

Class IIModerate

FDANov 9, 2022CA, FL, WA• DISCOVERY PHARMA LLC

Sodium Chloride Injection (ICU Medical) – Sterility Compromise (2022)

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Class II

1...101 102103104 105...547

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Moderate

FDANov 9, 2022Nationwide• ICU Medical Inc

BIOLOX Delta Mod Head (Corin) – Incorrect Size Labeling (2022)

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

Moderate

FDANov 8, 2022Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Arcoiris Marshmallow Cookies (Pepsico) - Salmonella Risk (2022)

Salmonella

Potential to contain Salmonella

Class IHigh

FDANov 7, 2022CA, TX• Comercializadora Pepsico Mexico,

Randox IgM Immunoturbidimetric Assay (Randox) – assay contamination risk (2022)

Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results

Moderate

FDANov 1, 2022Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Randox IgA Immunoturbidimetric Assay (Randox) – assay contamination risk (2022)

Moderate

FDANov 1, 2022Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Unity Total Knee System (Corin) – Packaging Damage (2022)

The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Moderate

FDAOct 31, 2022IN, PR• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Centricity Universal Viewer (GE Medical) – Hidden Studies (2022)

There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

Moderate

FDAOct 28, 2022Nationwide• GE Medical Systems, LLC

Centricity PACS-IW (GE Medical) – Hidden Studies (2022)

Moderate

FDAOct 28, 2022Nationwide• GE Medical Systems, LLC

Kalera Krunch Lettuce - salmonella risk (2022)

Salmonella

Potential contamination with Salmonella

Class IHigh

FDAOct 28, 2022Nationwide• Kalera Public Limited Company

Kalera Butter Lettuce - salmonella risk (2022)

Salmonella

Potential contamination with Salmonella

Class IHigh

FDAOct 28, 2022Nationwide• Kalera Public Limited Company

Kalera Baby Romaine Lettuce - salmonella risk (2022)

Salmonella

Potential contamination with Salmonella

Class IHigh

FDAOct 28, 2022Nationwide• Kalera Public Limited Company

CytoCell BCL11B Distal (Cytocell) – Chromomap Error (2022)

An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

Moderate

FDAOct 27, 2022TX• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

CytoCell BCL11B Proximal (Cytocell) – Mislabeling (2022)

Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert

Low

FDAOct 27, 2022TX• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

Cedar Creek Caramel Popcorn - gluten mislabeling (2022)

Label contains "Gluten Free" claim but product contains wheat and barley which are declared on the label.

Class IIModerate

FDAOct 27, 2022AZ, GA, IN +5 more• Rieckhoff Family Businesses, Inc dba Cedar Creek Popcorn

Zingerman's Pumpkin Gelato (Zingerman's) – undeclared egg (2022)

Undeclared Egg

undeclared egg

Class IHigh

FDAOct 24, 2022MI• Zingerman's Creamery, LLC

Zingerman's Paw Paw Gelato (Zingerman's) – undeclared egg (2022)

Undeclared Egg

undeclared egg

Class IHigh

FDAOct 24, 2022MI• Zingerman's Creamery, LLC

U-Line Outdoor Freezers – fire hazard (2022)

Fire/Burn Risk

This recall involves U-Line Outdoor Series 24-inch Built-In Convertible Freezers with model number U-1224FZRSOD-00A and manufactured between 2017-2018. They have serial number ranges between 1745627020001-1745627020009; 1746096040001-1746096040077; 1850469050001-1850469050003; and 1850469059001-1850469059003. The model number, serial number, and "U-Line" brand name are printed on a plate located in the top right interior of the unit.

High

CPSCOct 13, 2022Nationwide• U-Line Corporation, of Milwaukee, Wisconsin

Superion Decompression System (Boston Scientific) – Weld Breakage Risk (2022)

Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.

Moderate

FDAOct 12, 2022Nationwide• Boston Scientific Neuromodulation Corporation