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 ChemoLock 13mm Closed Vial Spike REF: CL-82 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 36 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical 31" Appx 3.4 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 8" Ext Set w/MicroClave Clear, ChemoLock 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
Surgical Navigation Advanced Platform Patient Engagement recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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Class II · 12 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , Large Volume Pump recall: Potential issue that can cause the device to register "phantom" touches
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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Class II · 12 months ago
Daye Refill 3 Month Heavy Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Refill 18 Coated Super and 18 Nude Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
MicroSurgical Technology Inc MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile recall: An ophthalmic knife has a suction set (not direct patient-contacting)
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may…
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Class II · 12 months ago
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 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
CareFusion 303, Inc. Various models of BD Pyxis Pro 7-Drawer Auxiliary 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
Daye Heavy Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Initiation 3 Month Regular Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class I · 12 months ago
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product recall: A software defect in version v1.15.0 of the G6 Android app can cause the app
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving…
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Class II · 12 months ago
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 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 Trial Tampon Box recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Surgical Navigation Advanced Platform , software version SNP.3.12.0 recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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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
Daye Initiation 36 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical ChemoLock Bag Spike REF: CL-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
Philips Medical Systems Model: Incisive CT 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…
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Class II · 12 months ago
ICU Medical 45" Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap 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 Initiation 3 Month All in One Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 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.