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Showing 601–620 of 11714 results

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BD Pyxis Pro MedStation (CareFusion) – fluid ingress risk (2025)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDASep 30, 2025Nationwide• CareFusion 303, Inc.

PRECISION1 Contact Lenses (Alcon) – sterility seal (2025)

Potential for a weak seal in some units resulting in compromise in sterility.

FDASep 30, 2025AL, AZ, AR +17 more• Alcon Research LLC

BD Pyxis Pro 7-Drawer (CareFusion) – fluid ingress risk (2025)

Fire/Burn Risk

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

High

FDASep 30, 2025Nationwide• CareFusion 303, Inc.

IMRIS Operating Suite (Impris) – MRI venting safety (2025)

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDASep 30, 2025Nationwide• IMPRIS Imaging Inc

IMRIS iMRI 3T V (Impris) – MRI venting safety (2025)

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDASep 30, 2025Nationwide• IMPRIS Imaging Inc

InVision 3T Operating Suite (Impris) – MRI venting safety (2025)

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDASep 30, 2025Nationwide• IMPRIS Imaging Inc

Leksell Stereotactic System (Elekta) – paint flake risk (2025)

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

FDASep 30, 2025Nationwide• Elekta, Inc.

Zenition 50 X-ray System (Philips) – image quality degradation (2025)

Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

FDASep 29, 2025MO, TX• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Enoki Mushrooms (New Age) – Listeria Contamination (2025)

Product may be contaminated with Listeria monocytogenes.

FDASep 29, 2025NY• New Age International, Inc.

Alcohol Prep Pads (Medline) – Subpotent Drug (2025)

Subpotent Drug

Class IIModerate

FDASep 29, 2025Nationwide• Medline Industries, LP

Wyandotte Sanifect E3 Sanitizer (Acuity) – Manufacturing Deviation (2025)

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

Class IIModerate

FDASep 29, 2025Nationwide• Acuity Specialty Products, Inc.

AFCO Hand Sanitizer (Acuity) – Manufacturing Deviation (2025)

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

Class IIModerate

FDASep 29, 2025Nationwide• Acuity Specialty Products, Inc.

Doxycycline Hyclate Tablets 100mg (Acella) – Dissolution Failure (2025)

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

Class IIModerate

FDASep 29, 2025Nationwide• Acella Pharmaceuticals, LLC

Brown Jumbo Eggs (Eggs Unlimited) – Salmonella Risk (2025)

Firm received, repackaged eggs that are potentially contamination with Salmonella.

FDASep 29, 2025CA, CT, IN +1 more• EGGS UNLIMITED LLC

Bona Fish (Vicky IT) – Contamination Concerns (2025)

Fish is un-eviscerated (may be contaminated with Clostridia botulinum), is contaminated with mold, and contains filth (insect larvae)

FDASep 27, 2025NY• Vicky IT Inc.

Cheesy Cauliflower Au Gratin (FreshRealm) – Listeria Risk (2025)

Potential contamination with listeria monocytogenes

Class IIModerate

FDASep 27, 2025Nationwide• FreshRealm, Inc

AART Chin Implant (DSAART) – specification deviation (2025)

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

FDASep 26, 2025AZ, AR, CA +24 more• DSAART LLC

Carescape B450 Monitor (GE) – battery performance (2025)

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

FDASep 26, 2025Nationwide• GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland

AART Malar Implant (DSAART) – specification deviation (2025)

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

FDASep 26, 2025AZ, AR, CA +24 more• DSAART LLC

MiraQ System (Medistim) – printer module failure (2025)

Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.

FDASep 26, 2025CO, MI, MN +2 more• Medistim Asa Okernveien

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