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

621 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

Fortress Introducer Sheath System Recalled Due to Labeling Error

Contract Medical International GmbH recalled 2,500 Fortress Introducer Sheath Systems on July 30, 2025. Units may have incorrect pouch labeling, leading to potential use of the wrong device version. Patients and healthcare providers should stop using the product immediately.

Contract Medical International GmbH
Units may
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HIGHFDA DRUG

Exela Pharma Recalls Sodium Bicarbonate Injection Over Arsenic Risk

Exela Pharma Sciences recalled 4.2% Sodium Bicarbonate Injection on July 30, 2025, due to arsenic contamination. The recall affects single-dose vials distributed nationwide. Consumers and healthcare providers must stop using the product immediately.

SODIUM BICARBONATE
Failed Impurities/Degradation
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HIGHFDA DEVICE

S.I.N. Implant System Recalls Dental Implants Over Quality Concerns

S.I.N. Implant System Ltda recalled 4,367 dental implants on July 30, 2025, due to improper storage conditions. The recalled products may have compromised packaging, affecting their quality and performance. Patients and healthcare providers should stop using these devices immediately.

S.I.N. Implant System Ltda
Dental implants
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Over Calibration Failures

Ortho-Clinical Diagnostics recalled 2,908 units of VITROS Chemistry Products LAC Slides on July 29, 2025. The recall affects lots from coating 0130 and above due to increased calibration failures that delay test results. The issue may impact patient management and was identified through an uptick in customer complaints.

Ortho-Clinical Diagnostics
VITROS Chemistry
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HIGHFDA DRUG

Pfizer Recalling Levoxyl Due to Subpotent Drug Hazard

Pfizer Inc. recalled 29,004 bottles of Levoxyl on July 29, 2025, due to subpotency. The recall affects levothyroxine sodium tablets, 50 mcg, Rx only, distributed in the U.S. Consumers should stop using the product immediately.

Levoxyl
Subpotent drug
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Due to Calibration Failures

Ortho-Clinical Diagnostics recalled 2,320 units of VITROS Chemistry Products LAC Slides on July 29, 2025. Calibration failures in lots from coating 0130 and above delay test results and may impact patient management. Healthcare providers and patients must stop using these slides immediately.

Ortho-Clinical Diagnostics
VITROS Chemistry
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HIGHFDA DEVICE

ORTOMA Inserter Adapter Recalled Due to Weld Breakage Hazard

ORTOMA AB recalled 261 Inserter Adapters on July 28, 2025, due to a potential weld failure. The defect poses a risk of improper positioning during hip implant procedures. The recall affects devices distributed worldwide, including the U.S. and countries like Japan and Sweden.

ORTOMA AB
Due to
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Laryngoscope Light Failure

Medline Industries, LP recalled 596 medical convenience kits on July 25, 2025. The recall affects kits with Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to light failure. Patients and healthcare providers must stop using these devices immediately.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Intubation Trays Due to Light Failure Hazard

Medline Industries, LP recalled 2,520 medical convenience kits on July 25, 2025. The recall affects multiple intubation trays containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles. The light in these devices fails to illuminate, posing a serious risk in emergency situations.

Medline Industries, LP
Medline Industries,
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HIGHFDA DRUG

Duloxetine Capsules Recalled Due to High N-nitroso Impurity

Towa Pharmaceutical Europe recalled 1,856 bottles of Duloxetine delayed-release capsules on July 25, 2025. The recall follows the discovery of N-nitroso-duloxetine impurity exceeding FDA limits. Consumers should stop using the product immediately and seek guidance.

DULOXETINE
CGMP Deviations:
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HIGHFDA DEVICE

Merit Medical Recalls Hemostasis Valve Over Foreign Body Risk

Merit Medical Systems recalled 447 units of the 10Fore Hemostasis Valve on July 25, 2025. A manufacturing issue may cause a deformed silicone quad ring, posing a risk of foreign body in the fluid pathway. This recall affects the U.S. and Canada.

Merit Medical Systems
Due to
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Recalled Pura 4 Smart Home Fragrance Diffuser with detachable cover
HIGH
CPSC

Pura Scents Recalls Fragrance Diffusers Over Magnet Ingestion Hazard

Pura Scents recalled detachable covers of its Smart Home Fragrance Diffusers on July 24, 2025. The covers contain magnets that can detach and pose an ingestion hazard to children. Consumers should stop using the product immediately and contact Pura Scents for a replacement.

Pura Scents
The magnets
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Recalled LIVACTI Retractable Safety Gate - Black
HIGH
CPSC

LIVACTI Safety Gates Recalled Due to Entrapment Risk

LIVACTI recalled retractable safety gates on July 24, 2025, due to serious entrapment hazards. The gates can pose a risk of injury or death to children. Consumers should stop using them immediately and seek refunds.

LIVACTI
The recalled
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Recalled Transpro A3 Hub Motor Electric Scooter
HIGH
CPSC

Transpro Recalls Electric Scooters Over Fire Risks

Transpro US recalled electric scooters on July 24 due to fire hazards. The A3 Hub Motor, A11F Spark, and R1 Commuter scooters have unauthorized lithium-ion battery certification labels. Consumers should stop using these scooters and contact Transpro for a refund or replacement.

Transpro US
The battery
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