Recalls published in September 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in September 2025, newest first.
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Class I · 1+ years ago
Boston Scientific Corporation Watchman FXD Curve Access System Dbl, US recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class II · 1+ years ago
Raysearch Laboratories Ab RayStation with the following product descriptions: 1 recall: DICOM SOP Instance UID and Series Instance UID from RayGateway
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
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Class II · 1+ years ago
Boston Scientific Neuromodulation Corporation Superion IDS Kit Superion Indirect recall: As a result of a comprehensive product performance review it was determine
As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected…
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Class II · 1+ years ago
Medshape Universal Joints, REF: DNE-9000-UJ recall: Bone external fixation system may have the pin that can become dislodged
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in…
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Class II · 1+ years ago
Integra LifeSciences Corp. Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste recall: Packaging failures were identified which could lead to a breach
Packaging failures were identified which could lead to a breach in the sterile barrier.
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Class I · 1+ years ago
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product recall: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0…
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Class II · 1+ years ago
Raysearch Laboratories Ab RayStation with the following product descriptions: 1 recall: DICOM SOP Instance UID and Series Instance UID from RayGateway
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System SGL, US recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class II · 1+ years ago
Raysearch Laboratories Ab RayStation with the following product descriptions: 1 recall: DICOM SOP Instance UID and Series Instance UID from RayGateway
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
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Class II · 1+ years ago
Lumicell, Inc. Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly recall: The potential of the elastic bands included in the kit detaching
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a…
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Class II · 1+ years ago
Visgeneer, Inc. Blood Uric Acid Monitoring System Each kit contains 1 meter recall: Due to products distributed without premarket clearance or approvals
Due to products distributed without premarket clearance or approvals.
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Class II · 1+ years ago
ICU Medical Inc. Smiths Medical CADD Medication Cassette Reservoir with clamp recall: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic…
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Class I · 1+ years ago
Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented recall: The catheters may not retain their shape
The catheters may not retain their shape.
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Class I · 1+ years ago
mo-Vis BVBA IDM-MICRO-R. Electrical wheelchair component recall: Devices with firmware versions 2.3 and lower may experience timing variations
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary…
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Class II · 1+ years ago
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy recall: Subpotent Drug
Subpotent Drug
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Class II · 1+ years ago
Immunocore, LLC Kimmtrak Injection, 100 mcg/0.5 mL, For intravenous Infusion After recall: Subpotent Drug
Subpotent Drug
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Class I · 1+ years ago
B Braun Medical Inc Lactated Ringers's Injection USP, 1000 mL container recall: Presence of Particulate Matter
Presence of Particulate Matter
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Class II · 1+ years ago
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy recall: Subpotent Drug
Subpotent Drug
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Class II · 1+ years ago
Amneal Pharmaceuticals, LLC chlorproMazine Hydrochloride Tablets, USP recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism…
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Class I · 1+ years ago
DermaRite Industries, LLC KleenFoam, Antimicrobial Foam Soap with Aloe Vera recall: Microbial Contamination of Non-Sterile Drug Product: The products were found
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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Class II · 1+ years ago
Amneal Pharmaceuticals, LLC Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism…
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Class I · 1+ years ago
DermaRite Industries, LLC DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin recall: Microbial Contamination of Non-Sterile Drug Product: The products were found
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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Class II · 1+ years ago
Amneal Pharmaceuticals, LLC chlorproMazine Hydrochloride Tablets, USP recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism…
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Class II · 1+ years ago
Amneal Pharmaceuticals, LLC chlorproMazine Hydrochloride Tablets, USP recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism…