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

Olympus Recalls EVIS EXERA II Bronchoscope Due to Safety Updates

Olympus Corporation of the Americas recalled 1,473 EVIS EXERA II Bronchoscopes on September 11, 2025. The recall addresses critical updates to the instructions for use when combined with laser and coagulation therapies. Healthcare professionals must stop using the device immediately and follow the manufacturer's instructions.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Bronchoscope Recalled Over Safety Instructions Update

Olympus Corporation of the Americas recalled 3,216 bronchoscope units on September 11, 2025. The recall affects 347 units in the U.S. and includes critical updates to instructions for use. Patients and healthcare providers must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Insulet Recalls Omnipod 5 App Over Insulin Delivery Risks

Insulet recalled 174,013 units of the Omnipod 5 iOS application on September 11, 2025. A software error can lead to the duplication of numbers during manual entry. This increases the risk of insulin overdelivery, potentially causing hypoglycemia.

Insulet
The failure
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HIGHFDA DEVICE

Olympus Bronchovideoscope Recalled Over Safety Concerns

Olympus Corporation of the Americas recalled the BF-H1100 bronchovideoscope on September 11, 2025, due to safety concerns when used with certain medical equipment. The recall affects 1,867 units distributed outside the U.S. Patients and healthcare providers should stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Recalls EVIS EXERA Bronchoscope Over Safety Concerns

Olympus Corporation of the Americas recalled 262 EVIS EXERA bronchoscopes on September 11, 2025. The recall addresses safety issues related to the use of bronchoscopes with laser and coagulation equipment. Healthcare providers and patients must stop using the devices immediately for safety reasons.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Boston Scientific Recalls TENACIO Pump Over Deflation Issues

Boston Scientific recalled 59 units of the TENACIO Pump with InhibiZone on September 11, 2025. The recall addresses potential inflation and deflation performance issues. Patients should stop using the device immediately and follow the manufacturer's instructions.

Boston Scientific
The potential
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HIGHFDA DEVICE

Olympus Recalls Bronchoscopes Due to Safety Concerns

Olympus Corporation recalled 1,070 EVIS EXERA II bronchoscopes on September 11, 2025. The recall addresses safety concerns regarding their use with laser and high-frequency therapy equipment. Healthcare providers should stop using these devices immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Bronchoscope Recalled Due to High-Risk Usage Issues

Olympus Corporation of the Americas recalled 116 units of the BF Type XT40 bronchoscope on September 11, 2025. The recall addresses safety concerns regarding the device's use with laser and high-frequency therapy equipment. Healthcare providers must halt use immediately and follow specific instructions from Olympus.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Bronchofiberscope Recalled Over Safety Concerns

Olympus Corporation of the Americas recalled the Bronchofiberscope Model No. BF-TE2 on September 11, 2025. The recall affects 5,287 units due to safety concerns when used with laser and high-frequency therapy equipment. Users should stop using the device immediately and contact Olympus for further instructions.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Bronchoscope Recall Due to Safety Concerns with Laser Use

Olympus Corporation of the Americas recalled the BF-1TH1100 bronchoscope on September 11, 2025. The recall addresses safety concerns regarding the use of the device with certain laser therapy equipment. Healthcare providers and patients must stop using this device immediately to ensure safety.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Bronchofiberscope Recalled Due to Safety Concerns

Olympus Corporation of the Americas recalled 1,007 bronchofiberscopes on September 11, 2025, due to safety concerns related to their use with laser and high-frequency therapy equipment. The recall affects devices distributed nationwide in the U.S. and involves additional instructions for safe use.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Recalls Bronchovideoscope BF-1TQ170 Due to Safety Updates

Olympus Corporation of the Americas recalled the Bronchovideoscope BF-1TQ170 on September 11, 2025. The recall affects 2,092 units distributed outside the U.S. Additional instructions for safe use with laser and other therapies prompted this action.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA FOOD

Harris Teeter Texas Toast Recalled Due to Undeclared Milk

Harris Teeter recalled 295 units of Asiago Texas Toast on September 11, 2025. The recall stems from undeclared milk allergens not listed on the packaging. Consumers should avoid the product and seek a refund or replacement.

Harris Teeter
Undeclared Milk.
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HIGHFDA DEVICE

Olympus Recalls Bronchovideoscope Due to Safety Concerns

Olympus Corporation of the Americas recalled 3 bronchovideoscopes on September 11, 2025, due to safety clarification updates. The recall affects 1,987 units distributed outside the US. Healthcare providers must stop using the device immediately to ensure patient safety.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Ferno-Washington Recalls Powered Ambulance Cot Over Safety Risk

Ferno-Washington Inc recalled 138 powered ambulance cots on September 11, 2025. The fastening post hardware may loosen, posing a risk of detachment during use. Users should stop using the product immediately and follow the recall instructions.

Ferno-Washington
The fastening
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HIGHFDA DEVICE

Olympus Recalls Bronchoscope Over Potential Safety Risks

Olympus Corporation of the Americas recalled 916 units of the EVIS EXERA III Bronchoscope BF-Q190 on September 11, 2025. The recall addresses safety concerns related to its use with laser and high-frequency therapy equipment. Healthcare providers must stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Additional IFU
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