These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

1,498 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 45,288 IV administration sets on October 29, 2025. The recall addresses a risk of backflow from secondary IV containers into primary containers. Users must stop using the product immediately and follow manufacturer instructions.

B Braun Medical
Potential for
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 100 IV administration sets on October 29, 2025, due to a backflow risk. The recall affects gravity IV and pump administration sets used with several infusion pumps. The potential for medication backflow poses a serious health risk to patients.

B Braun Medical
Potential for
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 5,100 IV administration sets on October 29, 2025. The recall affects devices used with Infusomat Space, Outlook, and Vista Basic Pumps. The product poses a high risk of medication backflow from secondary IV containers.

B Braun Medical
Potential for
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 2,544 IV Administration Sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers into primary IV containers. Healthcare providers and patients should stop using the devices immediately.

B Braun Medical
Potential for
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets for Backflow Risk

B Braun Medical recalled 122,232 IV administration sets on October 29, 2025. The recall addresses potential backflow of medication from secondary IV containers into primary containers. Affected units were distributed worldwide including the US, Canada, Germany, Guatemala, and Singapore.

B Braun Medical
Potential for
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 66,792 IV Administration Sets on October 29, 2025, due to a potential backflow risk. The recall affects models used with Infusomat Space, Outlook, and Vista Basic Pumps. Healthcare providers must stop using these devices immediately.

B Braun Medical
Potential for
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 3,120 IV administration sets on October 29, 2025, due to a risk of medication backflow. The recall affects models used with Infusomat Space, Outlook, and Vista Basic Pumps. The company advises patients and healthcare providers to stop using the devices immediately.

B Braun Medical
Potential for
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HIGHFDA DEVICE

B Braun Medical Recalls Anesthesia IV Sets Due to Backflow Risk

B Braun Medical recalled 19,320 Anesthesia IV Sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers. Patients and healthcare providers must stop using the device immediately.

B Braun Medical
Potential for
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HIGHFDA DEVICE

Medtronic Recalls Extravascular Implantable Defibrillators Over Hazard

Medtronic recalled 6,591 extravascular implantable cardioverter defibrillators on October 29, 2025. The recall stems from a potential delay in high-voltage therapy that could occur under rare conditions. Patients must stop using the devices immediately and follow manufacturer instructions.

Medtronic
There is
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HIGHFDA DEVICE

Philips CT Scanner Recalled Over Potential Detachment Hazard

Philips North America recalled six units of the Incisive CT scanner on October 29, 2025, due to a serious safety hazard. The screws on the tube heat exchanger may not be properly tightened, leading to potential detachment during operation. This defect could cause damage to other components within the system.

Philips North America
If the
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HIGHFDA DEVICE

Philips CT Scanner Recalled Due to Detachment Risk

Philips North America recalled 2,341 Incisive CT scanners on October 29, 2025. A component may detach and damage other parts during operation. Users must stop using the device immediately and follow recall instructions.

Philips North America
If the
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HIGHFDA DEVICE

Baxter Healthcare Recalls Blood Pressure Cuff Replacement Bladder

Baxter Healthcare recalled 118 units of the Welch Allyn INF BAG, Model REF 5089-18, on October 28, 2025. The replacement bladder may contain a Large Adult size bladder instead of a Thigh size bladder. This defect poses a high risk for inaccurate blood pressure readings.

Baxter Healthcare
Replacement bladder
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HIGHFDA DEVICE

Illumina Recalls NextSeq 550Dx Reagent Kits Over Flow Cell Leaks

Illumina recalled 11,916 NextSeq 550Dx reagent kits on October 28, 2025. Flow cell gaskets in these kits may leak during DNA sequencing runs, risking toxic exposure to users. Healthcare providers must stop using these devices immediately and follow recall instructions.

Illumina
An instrument
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HIGHFDA FOOD

Moonlight Packing Recalls Peppermint Peach Over Listeria Risk

Moonlight Packing Corporation recalled 439 bags of Peppermint Peach on October 28, 2025, due to potential Listeria monocytogenes contamination. The affected product weighs 2.25 lbs and may pose a serious health risk to consumers. The recall includes products distributed across multiple states and internationally.

Moonlight Packing
Potential contamination
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