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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 1841–1860 of 39,430 recalls

Class IIOngoing

IntelliVue Patient Monitor MX100. Product Number: 867033.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue MP40. Product Number: M8003A.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class II
Ongoing

Olympus OER-Elite

Aizu Olympus Co., Ltd.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Multi Measurement Server X2. Product Number: M3002A.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue MP60. Product Number: M8005A.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue MP5. Product Number: M8105A.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue MP20. Product Number: M8001A.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX600. Product Number: 865242.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

Stryker Arise 1000EX mattress, Part Number 2236000000

Stryker Medical Division of Stryker Corporation

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

October 31, 2025 · DeviceView details →
Class IIOngoing

Stryker MV3 bariatric bed, Part Number 5900000001

Stryker Medical Division of Stryker Corporation

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX400. Product Number: 866060.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Multi-Measurement Module X3. Product Number: 867030.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

Olympus OER-Pro

Aizu Olympus Co., Ltd.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX550. Product Number: 866066.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX750. Product Number: 866471.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

Olympus OER-Mini

Aizu Olympus Co., Ltd.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX450. Product Number: 866062.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

Stryker Corporation

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

October 31, 2025 · DeviceView details →
Class IIOngoing

IntelliVue MP70. Product Number: M8007A.

Philips North America Llc

Potential issue where the IntelliVue monitors did not alarm.

October 31, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Cepheid

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

October 30, 2025 · DeviceView details →
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