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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

426

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 261–280 of 4598 recalls

Optima MR450w 1.5T (GE Medical) – MR System Concern (2025)

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Moderate

FDAJun 20, 2025Nationwide• GE Medical Systems, LLC

Portable X-ray System (Digimed) – Minimum Distance Concern (2025)

Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

Low

FDAJun 19, 2025Nationwide• DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)

1...12 131415 16...230

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Honey Cough Syrup (Little Remedies) – Bacterial Contamination (2025)

contaminated with Bacillus cereus and may be spoiled

Class IIModerate

FDAJun 18, 2025Nationwide• Prestige Brands Holdings

SafeStar 60A Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Low

FDAJun 16, 2025Nationwide• Draeger, Inc.

SafeStar 55 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Low

FDAJun 16, 2025Nationwide• Draeger, Inc.

HME TwinStar HEPA Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Low

FDAJun 16, 2025Nationwide• Draeger, Inc.

Testosterone Pellet (Qualgen) – Incorrect Label Printing (2025)

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

Class IIILow

FDAJun 16, 2025Nationwide• Qualgen, LLC

SafeStar 90 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Low

FDAJun 16, 2025Nationwide• Draeger, Inc.

EasiSlush Solution (Bridge to Life) – Audit Timing Issue (2025)

The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.

Low

FDAJun 12, 2025Nationwide• Bridge to Life Ltd

Dodge Charger (Dodge) – Amplifier Software Omission (2025)

Chrysler (FCA US, LLC) is recalling certain 2024-2025 Dodge Charger vehicles. The amplifier may be missing software, which can prevent the amplifier from emitting exterior sound, including pedestrian warnings. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 141, "Minimum Sound Requirements for Hybrid Electric Vehicles."

High

NHTSAJun 12, 2025Nationwide• DODGE

LION Mixed Berry Spring Water – contamination risk (2025)

Potential contamination with floating objects

Class IIILow

FDAJun 11, 2025IN, TN• 3rd Day Beverages LLC

LION Lemon Lime Spring Water – contamination risk (2025)

Potential contamination with floating objects

Class IIILow

FDAJun 11, 2025IN, TN• 3rd Day Beverages LLC

LION Pineapple Spring Water – contamination risk (2025)

Potential contamination with floating objects

Class IIILow

FDAJun 11, 2025IN, TN• 3rd Day Beverages LLC

LION Watermelon Spring Water – contamination risk (2025)

Potential contamination with floating objects

Class IIILow

FDAJun 11, 2025IN, TN• 3rd Day Beverages LLC

Sedecal Mobile Digital X-Ray (SEDECAL) – Water Resistance Warning (2025)

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Low

FDAJun 10, 2025CA, IL, NJ• SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain

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GE Medical Systems, LLC Recalls

Recall Summary

Optima MR450w 1.5T (GE Medical) – MR System Concern (2025)

Portable X-ray System (Digimed) – Minimum Distance Concern (2025)

Honey Cough Syrup (Little Remedies) – Bacterial Contamination (2025)

SafeStar 60A Plus Filter (Draeger) – CO2 Sampling Issue (2025)

SafeStar 55 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

HME TwinStar HEPA Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Testosterone Pellet (Qualgen) – Incorrect Label Printing (2025)

SafeStar 90 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

EasiSlush Solution (Bridge to Life) – Audit Timing Issue (2025)

Dodge Charger (Dodge) – Amplifier Software Omission (2025)

LION Mixed Berry Spring Water – contamination risk (2025)

LION Lemon Lime Spring Water – contamination risk (2025)

LION Pineapple Spring Water – contamination risk (2025)

LION Watermelon Spring Water – contamination risk (2025)

Sedecal Mobile Digital X-Ray (SEDECAL) – Water Resistance Warning (2025)

SHIMADZU RF.004 X-ray (SEDECAL) – Water Resistance Warning (2025)

40KWFXPLUS.005 Mobile X-ray (SEDECAL) – Water Resistance Warning (2025)

40KWFXPLUS-710CW Mobile X-ray (SEDECAL) – Water Resistance Warning (2025)

SM-32HF Mobile X-ray (SEDECAL) – Water Resistance Warning (2025)

40KWFXPLUS Mobile X-ray (SEDECAL) – Water Resistance Warning (2025)