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 · 10 months ago
Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk recall: Treatment reagent functionality in respiratory specimens fluidification
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
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Class II · 10 months ago
Medline Industries, LP Scissors, OR, Sharp/Blunt, 5.5", Sterile recall: The items may have weak packaging seals that may result in a breach
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if…
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Class II · 10 months ago
Medtronic MiniMed, Inc. InPen App, Model/CFN Number: MMT-8061 recall: When app is uninstalled and reinstalled, insulin pen software issue causes
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't…
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Class II · 10 months ago
Seaspine Orthopedics Corporation Orthofix NorthStar OCT Navigation Surgical Technique recall: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards…
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Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
Zimmer Dermatome AN, Model/ recall: The devices may have a misaligned thickness control bar
The devices may have a misaligned thickness control bar.
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Class II · 10 months ago
Cepheid Brand Name: Xpert¿ BCR-ABL Ultra Model/ recall: Invitro diagnostic test kits with specimens that have elevated white blood
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
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Class I · 10 months ago
GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system recall: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power…
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Silicone Carving Implant Product Name: Silicone recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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Class II · 10 months ago
Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap recall: Treatment reagent functionality in respiratory specimens liquification cannot
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
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Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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Class II · 10 months ago
Fresenius Medical Care Holdings, Inc. 5008X CAREsystem +CLiC +CDX recall: Several software anomalies with the potential to impact patient treatment
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if…
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Class I · 10 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , LVP Software LVP-SW-0005. Software recall: Software version 5.10.1 and earlier contain anomalies that have the potential
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
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Class III · 10 months ago
Datascope Corp. Cardiosave Hybrid recall: The IFU addendum updates the Vibration and Shock Table to reference
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Malar Implant Product Name: Malar Implant Model/ recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class II · 10 months ago
AVID Medical, Inc. Halyard, Head AND Neck Tray recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
AVID Medical, Inc. Halyard, Major Pack recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
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Class II · 10 months ago
Dsaart LLC Brand Name: AART Calf Implant Product Name: Calf Implant Model/ recall: Due to manufactured products that deviated from established specifications
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket…
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Class I · 10 months ago
GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system recall: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power…
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Class III · 10 months ago
Datascope Corp. Cardiosave Rescue recall: The IFU addendum updates the Vibration and Shock Table to reference
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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Class II · 10 months ago
AVID Medical, Inc. Halyard, EP LAB PK recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.