infant product Recalls

794 recalls tagged with “infant product”.

Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems Israel Recalls 11 Elscint Cardial Gamma Cameras in 2025

GE Medical Systems Israel recalls 11 Elscint Cardial dual-head gamma cameras used for cardiac imaging worldwide. The recall concerns detector mounting that could fail if the unit is moved without proper support. Hospitals should stop using these devices immediately and follow GE’s recall instructions.

GE Medical Systems Israel
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

Argon Medical Devices Recalls 1,821 Option Elite IVC Filters for Dilator Resistance Risk (2025)

Argon Medical Devices recalled 1,821 Option Elite Vena Cava Filter System devices sold to U.S. hospitals and international distributors. The recall cites a dilator resistance issue within the introducer sheath that could slow procedures and injure venous tissue. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.

Argon Medical Devices
Due to
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Recalled Bottle of Bariatric Fusion High ADEK Multivitamin
HIGH
CPSC

Blueroot Health Recalls Bariatric Fusion Iron Multivitamins Over Child Poisoning Risk (2025)

Blueroot Health recalled Bariatric Fusion iron multivitamin bottles after discovering the packaging is not child-resistant. The recall involves two bottle types with 45 mg of iron. Affected bottles lack the required push-down-and-turn caps and carry specific lot numbers. Consumers should stop using the product and contact Blueroot Health for a free child-resistant replacement cap.

Blueroot Health
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1TH1100 Bronchoscope Recall Expanded for IFU Clarifications (2025)—High Risk

Olympus Corporation of the Americas reports an active recall for the BRONCHOVIDEOSCOPE BF-1TH1100. The recall concerns additional IFU updates for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. The company urges stopping use and following recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA III BF-1TH190 Bronchoscope Recall 8,587 Units in 2025

Olympus Corporation of the Americas recalls 8,587 bronchovideoscope units worldwide, including 4,297 in the US and 4,290 outside. The recall centers on updated IFU language for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer instructions for remediation.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1T60 Bronchofiberscope Recall for IFU Updates (2025)

Olympus recalled 3,216 BF-1T60 bronchofiberscopes distributed nationwide and internationally after updating instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. The recall updates guidance to reduce risk during advanced energy-device procedures. Clinicians and facilities should stop using the devices and follow manufacturer instructions for recall.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1TQ170 Bronchoscope Recall Expanded for IFU Clarifications

Olympus Corporation of the Americas recalls the BRONCHOVIDEOSCOPE BF-1TQ170. The recall is active with 2,092 units in the outside US market and no US units affected. The action seeks updated instructions for safe use with laser and high-frequency therapy equipment. Healthcare providers should stop use and follow manufacturer recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

OLYMPUS BF-1T150 Bronchoscope Recall in 2025 for Updated IFU on Safe Use

Olympus Corporation of the Americas recalled 1,990 BF-1T150 bronchoscopes distributed nationwide to healthcare providers. The recall updates the IFU to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-PE2 Bronchoscope Recall Expands with 4,289 Units Aboard Outside US

Olympus Corporation of the Americas confirms a Class I recall of the BRONCHOFIBERSCOPE BF TYPE PE2. The recall covers 2 units in the US and 4,289 units outside the US. Updated IFU guidance aims to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

CareFusion 303 BD Alaris Infusion Sets Recalled for Flow, Bolus Accuracy Issues (2025)

CareFusion 303 BD Alaris infusion pump modules and compatible infusion sets are recalled nationwide in the U.S. and multiple international markets. The recall covers reference numbers including C24101E and 10015414 and related SmartSite components. The defect may cause flow rate and bolus accuracy deviations, and incorrect occlusion timing. Stop using the device and follow recall instructions from

CareFusion
Infusion pump
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-H190 Bronchovideoscope Recall Expanded for IFU Updates in 2025

Olympus Corporation of the Americas recalls 5,221 units sold in the U.S. and 4,321 units overseas. The recall covers the EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. It flags updated instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Medline Excelsior Medical 0.9% Saline Flush Syringes Recalled Over Concentration Deviation (8.27M)

Medline Recall: Excelsior Medical 0.9% Sodium Chloride Injection, USP, 10 mL fill prefilled saline flush syringes EMZ111240 is being recalled. The notice covers 8,267,150 syringes distributed across the United States and Canada. The risk is a concentration deviation of sodium chloride. Healthcare facilities should stop using the product and follow recall instructions. See the FDA recall page for完整

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific CX Preconnect with TENACIO Pump Recall for Inflation Issues (2025)

Boston Scientific is recalling 1 CX Preconnect with TENACIO Pump sold to healthcare providers worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Healthcare providers and patients should stop using the device and follow manufacturer recall instructions.

Boston Scientific
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P150 Bronchoscope Recall Expanded Over IFU Clarifications (2025)

Olympus Corporation of the Americas recalls its BF-P150 bronchoscope after updates to the instruction for use. The recall covers 1,019 units outside the U.S. Distribution was nationwide in the U.S. The agency classifies this as a high-hazard issue.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-XT190 Bronchovideoscope Recall for IFU Updates Over Laser and HF Therapy Use

Olympus Corporation of the Americas recalls 361 units in the US and 258 units overseas as of September 11, 2025. The recall targets the EVIS EXERA b Bronchovideoscope BF-XT190. The update adds safety instructions for using bronchoscopes with laser, argon plasma coagulation, and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow a

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recall: Preconnect with TENACIO Pump with InhibiZone Affects 172 Units Worldwide

Boston Scientific recalled 172 units of the CXR Preconnect with TENACIO Pump with InhibiZone worldwide. The recall was initiated on 2025-09-11 and remains active as of 2025-10-22. The devices can experience inflation and/or deflation performance issues. Healthcare providers should stop using the devices and follow manufacturer instructions for recall remediation.

Boston Scientific
The potential
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Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Cookies Recalled for Undeclared Red 40 and Yellow 6

Gina Marie Bakery LLC recalls Vanilla with Apricot Jam Cookies due to undeclared artificial colorings Red 40 and Yellow 6. The recall, initiated by the state of Connecticut and notified to the FDA, involves 172 cases at 20 containers per case. FDA-listed recall status is ACTIVE with no reported incidents yet.

Gina Marie Bakery
Undeclared Red
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