Tennessee recalls
3590 federal recalls on file affecting Tennessee - 514 Tennessee-specific plus 3076 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-12-10FDA-DeviceAizu OlympusClass IINationwideOlympus OER-Pro
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2025-12-10FDA-DeviceAizu OlympusClass IINationwideOlympus OER-Elite
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2025-12-10FDA-DeviceParagon 28Class IINationwidePhantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX850. Product Number: 866470.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX750. Product Number: 866471.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX700. Product Number: 865241.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX600. Product Number: 865242.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX550. Product Number: 866066.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX450. Product Number: 866062.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX400. Product Number: 866060.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Patient Monitor MX100. Product Number: 867033.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Multi-Measurement Module X3. Product Number: 867030.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue Multi Measurement Server X2. Product Number: M3002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP80. Product Number: M8008A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP60. Product Number: M8005A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP40. Product Number: M8003A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilipsClass IINationwideIntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceFresenius KabiClass IINationwideIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- 2025-12-10FDA-DeviceBaxterClass IINationwideWelch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
- 2025-12-10FDA-DeviceGet TestedClass IINationwide8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwide3 in 1 STI Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwide2 in 1 Trichomonas / Gardnerella Test
Distribution without premarket approval/clearance.
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