Recalls published in December 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in December 2025, newest first.
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Class II · 11 months ago
Get Tested International Ab Gonorrhea test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Illumina, Inc. Reagent Kits/ containing flow cells, components of NextSeq 550Dx recall: An instrument intended for sequencing DNA libraries with in vitro diagnostic
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow…
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Class II · 11 months ago
Get Tested International Ab Chlamydia Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Gut Microbiome Test Large recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips North America Llc IntelliVue Patient Monitor MX600. Product Number: 865242 recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.
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Class II · 11 months ago
Get Tested International Ab Hair Mineral Analysis recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips North America Llc IntelliVue MP20. Product Number: M8001A recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.
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Class II · 11 months ago
Get Tested International Ab Organic acids Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips North America Llc IntelliVue MP5. Product Number: M8105A recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.
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Class II · 11 months ago
Get Tested International Ab Drug Test Small recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Lyme Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Biological Age & Longevity Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips North America Llc IntelliVue MP60. Product Number: M8005A recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.
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Class II · 11 months ago
Get Tested International Ab 3 in 1 STI Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Blood Type Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Menopause 2 Tests recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab 2 in 1 Trichomonas / Gardnerella Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Kidney Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Leaky Gut Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Enterix, Inc. InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE recall: InSure ONE failed sensitivity testing when used with Test Card Lot T241102
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
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Class II · 11 months ago
Get Tested International Ab Vitamin D2 and D3 Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab NAD Profile Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Food Intolerance Test Large recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Food Allergy Panel Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.