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
Microgenics Corporation Thermo scientific MAS Omni Cardio recall: The firm received complaints from customers reporting vial-to-vial
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This…
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Class II · 12 months ago
ICU Medical, Inc. ChemoLock Bag Spike, 01 units REF: CL-10-10 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
Daye Refill 3 Month Trial Tampon Box recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S 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 Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Siemens Healthcare Diagnostics, Inc. Assay: Immulite 2000 Intact PTH recall: The potential for falsely depressed Intact PTH patient results at the low end
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal…
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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 Bag Spike with Clave Additive Port REF: CL3940 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 9 Coated Regular and 9 Nude Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Vantive US Healthcare LLC Sharesource Connectivity Platform for Use with Homechoice recall: Vantive has identified a software defect within the Sharesource Claria
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to…
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Class II · 12 months ago
Daye Regular Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical 7.5" Appx 1.5 ml, Ext Set w/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
Daye 18 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 Oncology Kit w/31" 20 Drop Admin Set w/Integrated 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 w/Mini Bag Spike ¿ REF: C-17 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
SyncAR 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
Daye Initiation 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
Cepheid Xpert SA Nasal Complete recall: As a result of Post-Market half-time stability testing
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
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Class II · 12 months ago
Daye Initiation 18 Coated Regular and 18 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Greiner Bio-One Vacuette 2 ml 9NC Coagulation sodium citrate 3.2% recall: Blood collection tubes were manufactured with the label applied too high
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could…
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Class I · 12 months ago
IMPRIS Imaging Inc Imris Operating Suite, Imris iMRI 3T V 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 73" Appx 2.5 ml, Ext Set, Smallbore w/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
Daye Initiation 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
ICU Medical 6" Ext Set w/MicroClave" Clear 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.