Recalls published in November 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in November 2025, newest first.
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Class II · 12 months ago
ICU Medical 30" Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Canon Medical System, USA, INC. Vantage Galan 3T. Cmsc Model: MRT-3020/U7 recall: Affected system contains components that do not meet the required distance
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for…
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Class II · 12 months ago
Daye 9 Coated Super and 9 Nude Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Initiation 36 Coated Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical ChemoLock Vented Vial Spike, 20mm recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical ChemosafeLock Connecter REF: KL-FNU3 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Endomagnetics Ltd Magseed Pro 12 cm soft tissue marker recall: Potential for contamination with cotton fibers
Potential for contamination with cotton fibers.
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Class II · 12 months ago
CareFusion 303, Inc. BD Pyxis Pro MedStation Main, REF: 1155-00 recall: Potential fluid ingress of anesthesia station or med station may result
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
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Class II · 12 months ago
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices recall: Due to incomplete seals in the pouch which provide the sterile barrier
Due to incomplete seals in the pouch which provide the sterile barrier.
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Class II · 12 months ago
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class I · 12 months ago
IMPRIS Imaging Inc IMRIS Operating Suite, InVision 3T Operating Suite recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
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Class II · 12 months ago
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Daye 18 Coated Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Refill 3 Month Regular Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye 9 Coated Super Tampons and 9 Nude Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Refill 18 Coated Regular and 18 Nude Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Daye Refill 3 Month All in One Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class I · 12 months ago
IMPRIS Imaging Inc IMRIS Operating Suite, Neuro III-SV iMRI System recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
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Class II · 12 months ago
Philips Medical Systems Model: Incisive CT for Brazil SKD recall: Issue 1: The potential for unintentional continued gantry/couch movement
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2…