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
Philips North America Llc Incisive CT recall: If the screws of tube heat exchanger on the rotating scanner
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make…
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Class II · 11 months ago
Get Tested International Ab Heavy Metals 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 Peptic Ulcer 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 Allergy 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 Food Sensitivity 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 Mycotoxin Panel Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class I · 11 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System, LVP Primary Administration Set recall: Incorrect assembly of specific lot of LVP Primary Administration Set
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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Class II · 11 months ago
Get Tested International Ab Food Sensitivity 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 MP2. Product Number: M8102A 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
Siemens Medical Solutions USA, Inc Mammomat Fusion recall: There were instances where the operator table was sold together
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for…
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Class II · 11 months ago
Microbiologics Inc Kwik-Stik, Quality control kit for culture media recall: Some products packaged for lot 818-111-7 may have been packaged in pouches
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
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Class II · 11 months ago
Get Tested International Ab Food Intolerance Test Medium recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Siemens Medical Solutions USA, Inc Mammomat Inspiration recall: There were instances where the operator table was sold together
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for…
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Class II · 11 months ago
Get Tested International Ab Akkermansia 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 8 in 1 STI Test Kit 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 Small 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 MX850. Product Number: 866470 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 PSA Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Paragon 28, Inc. Phantom recall: Fibula nail system intended for use in fixation of fibular fractures
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so…
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Class II · 11 months ago
Get Tested International Ab Lactose Intolerance 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 Patient Monitor MX500. Product Number: 866064 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 Urinary Tract Infection 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 CT 5300 recall: If the screws of tube heat exchanger on the rotating scanner
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make…
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Class II · 11 months ago
Philips North America Llc IntelliVue Patient Monitor MX700. Product Number: 865241 recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.