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GE Medical Systems, SCS

GE Medical Systems, SCS Recalls

All product recalls associated with GE Medical Systems, SCS.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

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 621–640 of 3680 recalls

Allia IGS 5 Pulse X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

Interact Discovery RT X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

Allia IGS 7 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

1...30 313233 34...184

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High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

Innova IGS 6 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

Prelude Guide Sheath Roadster (Merit Medical) – Incorrect Dilator Risk (2024)

Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

Moderate

FDAMar 14, 2024Nationwide• Merit Medical Systems, Inc.

Residential Gas Boilers (U.S. Boiler) – Carbon Monoxide Risk (2024)

Fire/Burn Risk

This recall involves gas-fired residential boilers with brand names U.S. Boiler, New Yorker Boiler, Advantage, FORCE and Archer. The following boiler models that are currently installed at altitudes greater than 5,400 ft. above sea level are part of this recall. The U.S. boiler ES2 and Series 3 models are blue with a black top front and black vents on the front. The logo is located on the black top front of the boiler. The X-2 model has a solid teal color. The logo is located in the front middle of the boiler. The Lancer model is gray with a blue top. The logo is located in the front middle of the boiler. The Force G-3 model is solid gray. The logo is located in the front middle of the boiler. The CGE and CGF models are solid green The logo is located in the front middle of the boiler. The model and serial numbers are located on the boiler rating plate, which is on the top panel of the ES2 and Series 3 models, and on the inside vestibule (behind removable door) on the right side panel for X-2, CG-F, CG-E, AG , Force and Archer models. All of the models are about 40 inches tall from the floor to the top of the jacket. U.S. Boiler ES2 models ES23, ES24, ES25, ES26, ES27, ES28, ES29 (with or without "-N" or "-P" suffix) U.S. Boiler Series 3 models 303, 304, 305, 306, 307, 308, 309 (with or without "-N" or "-P" suffix) U.S. Boiler X-2 models X-202, X-203, X-204, X-205, X-206, X-207, X-208, X-209 New Yorker CG-E models CG30E, CG40E, CG50E, CG60E, CG70E, CG80E, CG90E New Yorker CG-F models CG20F, CG30F, CG40F, CG50F, CG60F, CG70F, CG80F, CG90F Advantage AG models AG3, AG4, AG5, AG6 FORCE models FORCE02E, FORCE03E, FORCE04E, FORCE05E, FORCE06E, FORCE07E, FORCE08E, FORCE09E Archer Boilers Lancer models LCR-2-038, LCR-3-068, LCR-4-102, LCR-5-136, LCR-6-170

Very High

CPSCMar 14, 2024Nationwide• U.S. Boiler Company LLC, of Lancaster, Pennsylvania

PIEZON Bottle (Electro Medical Systems) – Bottle Collar Separation (2024)

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Moderate

FDAMar 13, 2024Nationwide• Electro Medical Systems SA Chemin De La Vuarpilliere

Cleaner Bottle (Electro Medical Systems) – Bottle Collar Separation (2024)

Moderate

FDAMar 13, 2024Nationwide• Electro Medical Systems SA Chemin De La Vuarpilliere

Water Bottle (Electro Medical Systems) – Bottle Collar Separation (2024)

Moderate

FDAMar 13, 2024Nationwide• Electro Medical Systems SA Chemin De La Vuarpilliere

Thai Jasmine Rice (Otis McAllister) – Glass Fragment (2024)

Foreign object; piece of glass.

Class IIModerate

FDAMar 6, 2024OR, TX, UT +1 more• Otis McAllister

Neria Soft Infusion Set (Unomedical) – Incorrect Instructions (2024)

Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.

Low

FDAMar 5, 2024Nationwide• Unomedical A/S Osted Aholmvej 1

Treprostinil Injection (Par) – particulate matter (2024)

Presence of Particulate Matter.

Class IHigh

FDAMar 4, 2024Nationwide• Par Sterile Products LLC