Health & Personal Care Recalls

Boston Scientific TENACIO Pump Recall 2025 for Inflation Deflation Issues

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

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

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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

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.

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

Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

Ethicon Endo-Surgery ECHELON 80 mm Blue Linear Cutter Recalled for Unsterilized Shipment (3 Units, 3

The devices were shipped unsterilized.

Theken Companies Recalls 409 iNSitu Bipolar Hip System Heads for Sterile Barrier Risk (2025)

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

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

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

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

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

Olympus BF-TE2 Bronchofiberscope Recall for IFU Updates in 2025

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Olympus BF-H1100 Bronchovideoscope Recall 1,867 Units Overseas in 2025

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Abbott TactiFlex Sensor Ablation Catheter Recalled for Tip Detachment Risk (2025)

Abbott recalls 399 TactiFlex Sensor Enabled Ablation Catheters after reports of tip detachment during packaging removal. The recall covers devices worldwide. Stop using the device immediately and follow manufacturer instructions.

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

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Abbott TactiFlex Sensor Enabled Ablation Catheter Recall 3,403 Units Worldwide (2025)

Abbott recalled 3,403 TactiFlex Sensor Enabled Ablation Catheters sold worldwide. The devices may detach a tip during removal from packaging. Hospitals and providers should stop using the devices and follow the manufacturer’s recall instructions.

Abbott TactiFlex Ablation Catheter Recalled for Tip Detachment Risk (11,805 units, 2025)

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Biomet Juggerknot Mini Soft Anchors 912080 Recall 40 Units Nationwide 2025

The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.