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 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 I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System SGL, OUS 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
Integra LifeSciences Corp. Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel 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 II · 1+ years ago
Integra LifeSciences Corp. Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS 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
mo-Vis BVBA IDM-MULTI-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 I · 1+ years ago
mo-Vis BVBA All-round Joystick R-net Light. 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 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
Integra LifeSciences Corp. Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube 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
mo-Vis BVBA Idm-Arlite-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 I · 1+ years ago
Boston Scientific Corporation Watchman TruSteer Access System, 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
Integra LifeSciences Corp. Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel 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 II · 1+ years ago
Premia Spine Ltd Tops Inserter, part of the Tops System Instrument Set used recall: Potential for missing pins at tip of inserter
Potential for missing pins at tip of inserter.
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Class I · 1+ years ago
Baxter Healthcare Corporation Novum IQ Syringe Pump, Product Code 40700BAX recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP)…
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Class II · 1+ years ago
Integra LifeSciences Corp. Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet 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 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
Bio-Rad Laboratories, Inc. Platelia Toxo IgM recall: Due to a risk of false positive results that could lead to unnecessary
Due to a risk of false positive results that could lead to unnecessary medical treatment.
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Class II · 1+ years ago
Philips Allura System configured with a 1 Phase UPS. Allura family recall: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not…
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Class III · 1+ years ago
Flosonics Medical FloPatch FP120, REF: FP120-FOT01-005 recall: Flowmeter patch as a human readable expiry date on the outer shipping
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
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Class II · 1+ years ago
Preat Corp NobelBiocare Tri-Lobe-compatible WP X 6.0mm recall: Engaging titanium base was manufactured 180 degrees around the post
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the…
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Class I · 1+ years ago
Brand Name: Dexcom ONE+ 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
Merge Hemo, Model RCSV2, Model/ recall: Merge Healthcare has been informed by Schiller AG (Baar
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where…
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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
Physio-Control, Inc. Lifepak 1000 Part / Catalog Numbers / Udi-Di code: 320371500023 / recall: Due to required inspections not being performed on products/units that have
Due to required inspections not being performed on products/units that have gone through servicing.
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Class II · 1+ years ago
RefleXion X1 Model RXM1000 UDI Codes: 00860003983812 230504 X11001 recall: Due to incorrect software configuration that potentially allows more than two
Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could…