fda regulated Recalls

GET TESTED INTERNATIONAL AB Parasite Test Recalled for Distribution Without Premarket Approval

Distribution without premarket approval/clearance.

Cipla Recalls Phytonadione Injectable Emulsion Due to Stability Issues

Failed Stability Specifications: Observed OOS results: eg results for colour index

Stryker Recalls Arise 1000EX Mattresses Over Compatibility Issues

Stryker recalled 289 Arise 1000EX mattresses on October 31, 2025. The recall affects products sold nationwide due to potential incompatibility with MV3 beds. Users should stop using these mattresses immediately.

Philips IntelliVue MP40 Recall 1.9M Monitors Over Alarm Failure (2025)

Potential issue where the IntelliVue monitors did not alarm.

Philips IntelliVue MX100 Patient Monitors Recalled for Alarm Failure (Z-0861-2026)

Potential issue where the IntelliVue monitors did not alarm.

Philips IntelliVue MX600 Patient Monitor Recall 2025 for Alarm Failure

Potential issue where the IntelliVue monitors did not alarm.

Philips IntelliVue M3002A Recall Over Alarm Failure Affects 1,913,441 Units (2025)

Potential issue where the IntelliVue monitors did not alarm.

Stryker Recalls 39,148 NICO BrainPath BrainPath Shephard's Hook Devices Over Latex Packaging (2026)

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

PHILIPS IntelliVue MP80 Recall 1,913,441 Monitors Worldwide for Alarm Failure (2025)

Potential issue where the IntelliVue monitors did not alarm.

Nivagen Zinc Oxide Ointment Recall 912 Containers Over cGMP Deviations (2025)

Philips IntelliVue MP2 Monitors Recalled for Alarm Failure in 2025 (1,913,441 Units)

Philips North America is recalling 1,913,441 IntelliVue MP2 patient monitors worldwide. The devices may fail to alarm when critical conditions arise. Hospitals should stop using the monitors and follow Philips recall instructions.

Aizu Olympus OER-Elite Medical Device Recall Affects 6,578 US Units (2025)

Philips IntelliVue MP20 Recall Expands to 1.9 Million Units Over Alarm Failure Risk (2025)

Philips recalls 1.913 million IntelliVue MP20 patient monitors worldwide because the devices may fail to alarm. The issue could prevent critical alerts from sounding. Hospitals should stop using the monitors immediately and follow Philips recall instructions.

Philips IntelliVue MP60 Recall for Alarm Failure Affects 1,913,441 Monitors (2025)

Philips North America is recalling 1,913,441 IntelliVue MP60 patient monitors. The monitors may fail to alarm as designed. Hospitals and clinics using MP60 units should stop using the devices and follow the recall instructions.

Philips IntelliVue MX700 Recall Affects 1,913,441 Monitors Worldwide (2025)

Potential issue where the IntelliVue monitors did not alarm.

Philips IntelliVue MP5 M8105A Recall: 1,913,441 Monitors Worldwide Alarm Failure (2025)

Potential issue where the IntelliVue monitors did not alarm.

Philips IntelliVue Patient Monitor MX800 Recalled for Alarm Failure

Potential issue where the IntelliVue monitors did not alarm.

STRYKER NICO Myriad Handpiece Recall for 39,148 Units Worldwide (2026)

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

Kroger Recalls Halloween Skeleton Wax Candles for Fire Hazard (2025)

Crate & Barrel Recalls Ana Dining Chairs Across 15 SKUs for Fall Hazard (2025)