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

2,251 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

Zimmer Recalls Affixus Antegrade Femoral Nails Over Fracture Risk

Zimmer, Inc. recalled the Affixus Antegrade Femoral Nail on December 2, 2025, due to a risk of fatigue fractures. The recall affects three units distributed nationwide across several states. Patients should stop using the device immediately and consult healthcare providers for further instructions.

Zimmer
Affected implants
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HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Due to Fracture Risk

Zimmer recalled 11 Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may fracture, leading to serious health risks. Patients should stop using the device immediately and follow manufacturer instructions.

Zimmer
Affected implants
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HIGHFDA DEVICE

Microbiologics Recalls KWIK-STIK Over Testing Failure Risk

Microbiologics recalled 86 units of the KWIK-STIK 2-Pack on December 2, 2025. The affected products may fail to recover the target microorganism Campylobacter jejuni. This recall affects units distributed worldwide, including the U.S.

Microbiologics
Affected units
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HIGHFDA DEVICE

Zimmer Recalls Affixus Antegrade Femoral Nails Over Fracture Risk

Zimmer Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, leading to potential health risks. Patients should stop using the devices immediately and contact their healthcare provider.

Zimmer
Affected implants
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HIGHFDA DEVICE

Affixus Antegrade Femoral Nailing System Recalled Over Fatigue Risk

Affixus recalled 22 units of its antegrade femoral nailing system on December 2, 2025, due to a risk of implant fatigue fracture. The defect may lead to serious health complications including tissue damage and pain. Consumers and healthcare providers must stop using the affected implants immediately.

Zimmer
Affected implants
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HIGHFDA DEVICE

Affixus Antegrade Femoral Nails Recalled Over Fracture Risk

Zimmer, Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, risking implant fatigue fracture. This defect can cause severe health issues, including pain and tissue damage requiring surgery.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Affixus Femoral Nailing System Recalled Over Fracture Risk

Affixus recalled its Antegrade Femoral Nailing System on December 2, 2025, due to a potential implant fatigue fracture risk. The recall affects 22 units distributed nationwide in 14 states. Patients should stop using the affected devices immediately to avoid serious health risks.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Affixus Antegrade Femoral Nails Recalled Over Fracture Risk

Zimmer Inc. recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have undersized distal diameters, leading to potential fractures. Users should stop using the product immediately and contact their healthcare provider.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Due to Fracture Risk

Zimmer Inc. recalled 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have undersized distal diameters, risking implant fatigue fractures. Consumers should stop using the device immediately and follow manufacturer instructions.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Antegrade Femoral Nails Over Fracture Risk

Zimmer recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025, due to a risk of implant fatigue fracture. Affected implants may cause serious health issues, including tissue damage and pain. Healthcare providers must stop using the device immediately and follow recall instructions.

Zimmer
Affected implants
Read more
HIGHFDA FOOD

Fazt & Loud Energy Drink Recalled Over Caffeine Misprint

Fazt & Loud LLC recalled its Sour Gummy Bear energy drinks on December 2, 2025. The product contains 300 mg of caffeine instead of the labeled 150 mg. Consumers should stop using the product and seek a refund or replacement.

Fazt & Loud
Recall is
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HIGHFDA DEVICE

BD Catheter Recalled Due to Incorrect Expiration Labeling

BD recalled 149,310 hydrophilic catheters due to a labeling error regarding expiration dates. The recall affects the 14 Fr (4.7 mm) straight tip model, REF: RTU14F. Healthcare providers and patients must stop using the product immediately.

HANGZHOU BEVER MEDICAL DEVICES CO.
Labeling error,
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HIGHFDA DEVICE

RaySearch Laboratories Recalling Radiation Therapy Software Due to Safety Risk

RaySearch Laboratories AB recalled 22 units of its radiation therapy treatment planning system on November 28, 2025. The recall affects software versions RayStation 11B and its updates due to a high hazard risk. The software may not invalidate calculated radiation doses correctly under certain conditions, potentially impacting patient safety.

RAYSEARCH LABORATORIES AB
Potential for
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HIGHFDA DEVICE

Baxter Healthcare Recalls SIGMA Spectrum Infusion Pump Over Infusion Risk

Baxter Healthcare recalled 585 SIGMA Spectrum Infusion Pumps on November 28, 2025, due to a defect that may cause over-infusion. The affected model is the 35700BAX2, which has been distributed nationwide. Users must stop using the device immediately and follow recall instructions.

Baxter Healthcare
Certain pumps
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HIGHFDA DEVICE

RayStation Recalls Radiation Therapy System Over Dose Calculation Flaw

RaySearch Laboratories AB recalled its RayStation/RayPlan system on November 28, 2025. The recall affects software version RayStation 10B SP1, citing a high-risk hazard in radiation dose calculations. Affected systems may not invalidate doses as intended for certain Regions of Interest.

RAYSEARCH LABORATORIES AB
Potential for
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HIGHFDA FOOD

Mondelez Recalls Ritz Peanut Butter Crackers Over Allergen Risk

Mondelez Global recalled 70 cases of Ritz Peanut Butter Cracker Sandwiches on November 28, 2025. The recall stems from undeclared peanut allergens due to mispackaging. The affected product was distributed in eight states including Alabama and New York.

Mondelez Global
Undeclared allergens
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