All Product Recalls

Browse through 1,551 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DEVICE

Olympus Recalls Bronchovideoscope Over Safety Instructions Update

Olympus Corporation of the Americas recalled the Bronchovideoscope BF Type P150 on September 11, 2025. The recall affects 1,019 units distributed outside the U.S. This action follows updates to the instructions for use regarding safe operations with laser and high-frequency therapy equipment.

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 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

CareFusion 303 Recalls Infusion Pump Sets Due to Performance Issues

CareFusion 303 recalled Alaris Pump Infusion Sets on September 11, 2025, after identifying performance issues. The recall affects multiple model numbers due to potential inaccuracies in flow rate and alarm settings. Healthcare providers must stop using these devices immediately and follow recall instructions.

CareFusion 303
Infusion pump
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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 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 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 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 Bronchofiberscope Recalled Over Safety Instructions Update

Olympus Corporation of the Americas recalled 4,289 bronchofiberscopes on September 11, 2025. The recall addresses important updates to the instructions for use when combined with specific medical equipment. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Recalls EVIS EXERA III Bronchovideoscope Over Safety Hazard

Olympus Corporation of the Americas recalled 5,221 units of the EVIS EXERA III Bronchoscope BF-H190 on September 11, 2025. The recall aims to address safety concerns when used with laser and high-frequency therapy equipment. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Boston Scientific Recalls CX Preconnect Pump Over Performance Issues

Boston Scientific recalled one CX Preconnect with TENACIO Pump due to inflation and deflation performance issues. The recall affects models UPN 72404486 and UPN 72404488 distributed in the US and Canada. The recall was issued on September 11, 2025, and remains active as of October 22, 2025.

Boston Scientific
The potential
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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

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 III Bronchoscope Over Safety Concerns

Olympus Corporation recalled 4,297 EVIS EXERA III bronchoscopes on September 11, 2025. The recall follows updates to the instructions for use regarding safe operation with laser and high-frequency therapy equipment. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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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

Olympus Recalls Bronchoscope Over Safety Instructions Clarification

Olympus Corporation recalled 619 bronchoscope units on September 11, 2025. The recall affects the EVIS EXERA b BRONCHOVIDEOSCOPE BF-XT190 due to additional instructions for safe use. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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