cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA II BF-P180 Bronchovideoscope Recalled; 3,250 Units Affected Worldwide (2025)

Olympus Corporation of the Americas recalls 3,250 EVIS EXERA II BF-P180 Bronchovideoscopes sold in the United States and internationally. The recall updates the instructions for use to clarify safe and effective use with laser, argon plasma coagulation, and high-frequency therapy equipment. Healthcare providers should stop using the device immediately and contact Olympus for instructions.

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

Olympus BF-Q180-AC Bronchoscope Recall Due to Safety Issues - Stop Using Now

Olympus recalled 395 EVIS EXERA II bronchoscopes after updates revealed safety concerns. The bronchoscope's instructions for use with laser and coagulation equipment lacked clarity, posing high risks during procedures. Patients and healthcare providers must stop using this device and follow recall instructions immediately.

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

Insulet Omnipod 5 iOS App Recall Affects 174,013 Units in 2025

Insulet recalled 174,013 Omnipod 5 iOS app software units distributed nationwide in the United States. The recall cites a magnifying feature bug that can duplicate a single-digit entry. This could lead to bolus insulin dosing errors and hypoglycemia. Stop using the app immediately and follow recall instructions from Insulet or your healthcare provider.

Insulet
The failure
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-XT160 Bronchoscope Recall Due to High Hazard Risk — 262 Units Affected

Olympus recalled 262 units of the BF-XT160 bronchoscope after concerns regarding its safe use with laser and high-frequency therapy equipment. Additional instructions for use (IFU) updates clarify potential hazards. Healthcare providers and patients must cease use immediately and follow the manufacturer's recall instructions.

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

Olympus BF-P60 Bronchoscope Recall Affects 6,450 Units in 2025 for IFU Updates

Olympus recalled 6,450 BF-P60 bronchofiberscopes worldwide after updated instructions clarify safe use with laser, argon plasma coagulation and high-frequency therapy devices. The recall covers 1,007 US units and 5,443 units outside the US. Healthcare providers should stop using the device immediately and follow manufacturer instructions. Contact Olympus Corporation of the Americas for guidance.

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

Boston Scientific TENACIO Pump Recall 2025 for Inflation Deflation Issues

Boston Scientific recalled the TENACIO Pump without InhibiZone (UPN 72404420) worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.

Boston Scientific
The potential
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA III BF-Q190 Bronchovideoscope Recall Expands in 2025 for IFU Updates

Olympus Corporation of the Americas recalled 916 BF-Q190 bronchovideoscopes in the United States and 1,402 outside the US. The recall seeks to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall guidance.

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

Olympus BF-TE2 Bronchofiberscope Recall for IFU Updates in 2025

Olympus Corporation of the Americas recalls the BF-TE2 bronchofiberscope distributed nationwide in the United States. The recall updates the Instructions for Use to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall instructions.

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

Olympus BF-P190 Bronchoscope Recall Updated for 2025 IFU Guidance

Olympus recalls 3,046 BF-P190 bronchovideoscopes sold nationwide in the US and 2,414 overseas. The recall centers on updated IFU guidance to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Clinicians and facilities should stop using the device immediately and follow Olympus recall instructions.

Olympus
Additional IFU
Read more
Food & Beverages
HIGH
FDA FOOD

Tropicana Brands Group Recalls 1,599 Cases of Dole Apple Juice 15.2 oz PET (2025)

Tropicana Brands Group recalled 1,599 cases of Dole Apple Juice in 15.2 oz PET bottles. The recall covers products distributed to 11 states. A manufacturing process deviation may cause spoilage or microbial contamination and affect shelf stability. Consumers should not consume the product and should contact Tropicana Brands Group for refund or replacement by telephone.

Tropicana Brands Group
A manufacturing
Read more
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
Read more
Health & Personal Care
CRITICAL
FDA DEVICE

Abbott TactiFlex Sensor Ablation Catheter Recall 2025 Affects 1,958 Units

Abbott recalled 1,958 TactiFlex Sensor Enabled Ablation Catheters worldwide. A limited number of tip detachment events occurred during catheter removal from packaging. Patients and healthcare providers should stop using the device immediately and follow Abbott's recall instructions.

Abbott
Abbott has
Read more
Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Biscotti Recalled for Undeclared Red 40

Gina Marie Bakery LLC recalled 172 cases of Toasted Almond & Cherry Biscotti after the FDA flagged undeclared Red 40. The recall is classified as high hazard. Consumers should avoid the product and contact the company for refunds or replacements.

Gina Marie Bakery
Undeclared Red
Read more
Previous
12345...103
Next

Tag Statistics

Total Recalls
2,056

Related Tags

fda regulatedimmediate actionstop use immediatelyreturn for refundreplacement availablenhtsa regulatedfire hazardburn riskelectrical hazardsuffocation riskinfant productadult product