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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

620

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 81–100 of 10937 recalls

LOGIQ P10 HD Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

FDASep 18, 2025Nationwide• GE Medical Systems, LLC

Kirkland Signature Ahi Tuna Wasabi Poke – Listeria Contamination (2025)

Listeria

Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke.

Class IHigh

FDASep 18, 2025AL, AK, AR +34 more• Western United Fish Company Inc

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

1...3 456 7...547

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FDASep 16, 2025Nationwide• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Dried Bean Curd (G&L Food) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared allergen (wheat).

Class IIILow

FDASep 16, 2025CA• Gansu Zhaofeng Agricultural Development Co., Ltd.

Oxytocin IV Solution (IntegraDose) – No Active Ingredient (2025)

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

Class IHigh

FDASep 16, 2025Nationwide• IntegraDose Compounding Services LLC

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

FDASep 16, 2025Nationwide• Medtronic Sofamor Danek USA Inc

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

FDASep 15, 2025AK, CA, FL +5 more• FUJIFILM Healthcare Americas Corporation

Bupropion XL Tablets (Graviti) – Tablet Specification Failure (2025)

Failed Tablet/Capsule Specifications

Class IIModerate

FDASep 15, 2025Nationwide• Graviti Pharmaceuticals Private Limited

Millenium MPS (GE Medical) – Service End Risk (2025)

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

FDASep 12, 2025Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel

Affinity NT Oxygenator (Medtronic) – Gas Transfer Defect (2025)

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

FDASep 12, 2025AZ, CA, TN• Medtronic Perfusion Systems

Elscint Cardial (GE Medical) – Service End Risk (2025)

FDASep 12, 2025Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel

Stay Informed

GE Medical Systems, LLC Recalls

Recall Summary

LOGIQ P10 HD Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

Kirkland Signature Ahi Tuna Wasabi Poke – Listeria Contamination (2025)

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Dried Bean Curd (G&L Food) – Undeclared Wheat (2025)

Oxytocin IV Solution (IntegraDose) – No Active Ingredient (2025)

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

Bupropion XL Tablets (Graviti) – Tablet Specification Failure (2025)

Millenium MPS (GE Medical) – Service End Risk (2025)

Millenium MPR (GE Medical) – Service End Risk (2025)

Optima NX (GE Medical) – Service End Risk (2025)

Elscint Model 4XX (GE Medical) – Service End Risk (2025)

Elscint Helix (GE Medical) – Service End Risk (2025)

Millenium Myosight (GE Medical) – Service End Risk (2025)

Elscint Varicam (GE Medical) – Service End Risk (2025)

Sopha Medical Vision (GE Medical) – Service End Risk (2025)

Elscint SPX6 (GE Medical) – Service End Risk (2025)

Maxicam (GE Medical) – Service End Risk (2025)

Affinity NT Oxygenator (Medtronic) – Gas Transfer Defect (2025)

Elscint Cardial (GE Medical) – Service End Risk (2025)