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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

1000

Class I (Serious)

127

Most Recent

Jan 2026

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 1361–1380 of 25000 recalls

Discovery XR656 HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

Moderate

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

SinuCleanse Neti Pot (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Class IHigh

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

SinuCleanse Saline Packets (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

1...67 686970 71...1250

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Class I

High

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

SinuCleanse Soft Tip Bottle (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Class IHigh

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

Tissue Approximation System (TAS) – strap breakage (2025)

Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.

High

FDAJan 27, 2025Nationwide• TAS Medical Inc

Prelude IDEAL Sheath Introducer (Merit) – incorrect dilator (2025)

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

Low

FDAJan 27, 2025Nationwide• Merit Medical Systems, Inc.

Dark Chocolate Pretzels (Woodstock Farms) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared Allergen - Milk

Class IHigh

FDAJan 27, 2025NY• United Natural Trading Inc. dba Woodstock Farms

Bake at Home Sugar Cookie (Amazon Fresh) – Undeclared Egg (2025)

Undeclared Egg

Undeclared egg.

Class IHigh

FDAJan 25, 2025Nationwide• Amazon Retail LLC

Jumbo Sugar Cookie (Amazon Fresh) – Undeclared Egg (2025)

Undeclared Egg

Undeclared egg.

Class IHigh

FDAJan 25, 2025Nationwide• Amazon Retail LLC

Coachmen Catalina Trailer (Coachmen) – incorrect placard (2025)

Forest River, Inc. (Forest River) is recalling certain 2025 Coachmen Catalina travel trailers. The Federal Placard label lists an incorrect vehicle dry weight.

High

NHTSAJan 24, 2025Nationwide• COACHMEN

Lumenis Pulse Laser System (Lumenis) – charger overheating (2025)

The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.

High

FDAJan 23, 2025PA• LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel

Carvedilol Tablets 25mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Phenylephrine Injection (Provepharm) – Particulate Matter (2025)

Presence of Particulate Matter.

Class IHigh

FDAJan 21, 2025Nationwide• Provepharm Inc.

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Badger Sunscreen SPF 50 (Badger) – Labeling Omission (2025)

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

Class IIILow

FDAJan 17, 2025Nationwide• The W.S. Badger Company, Inc.

Ram 3500 (Ram) – side airbag inflator (2025)

Chrysler (FCA US, LLC) is recalling certain 2016-2019 Ram 3500, Ram 1500, 2016-2020 Ram 2500, and 2016 Ram 3500 Cab Chassis vehicles. The right and left side curtain air bag inflators may rupture due to a manufacturing defect.

High

NHTSAJan 16, 2025Nationwide• RAM

RayStation Planning System (RaySearch) – density uncertainty (2025)

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Moderate

FDAJan 16, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden