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
mo-Vis BVBA Micro Joystick R-net. 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 FXD Curve Access Sys Dbl, 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
Philips Azurion System configured with a 1 Phase UPS. Azurion 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 I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System DBL, 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
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
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 I · 1+ years ago
Baxter Healthcare Corporation Novum IQ LVP , Product Code 40700BAXUS, infusion pump 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 I · 1+ years ago
Boston Scientific Corporation Watchman FXD Curve Access Sys 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¿ Adhesive 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
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
ICU Medical Inc. Smiths Medical CADD" Medication Cassette Reservoir with flow stop 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 II · 1+ years ago
Integra LifeSciences Corp. Brand Name: CVS Honey Pad Product Name: CVS Honey Pad 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
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 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 II · 1+ years ago
Caris Life Sciences MI Cancer Seek REF MSC000 UDI Code: 00860008613325 H5Hjhdsxf MI recall: Due to an incorrect test results provided that indicated the incorrect drug
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
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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
Physio-Control, Inc. Lifepak 15 Part / Catalog Numbers / Udi-Di code: V15-7-000022 / 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
ICU Medical Inc. Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir 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
Boston Scientific Corporation Watchman TruSeal 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
Physio-Control, Inc. Lifepak CR2 Part / Catalog Numbers / Udi-Di code: CR2-2-001451 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 I · 1+ years ago
Baxter Healthcare Corporation Novum IQ Syringe Pump 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
Medtronic MiniMed, Inc. InPen App, CFN: MMT-8060 and MMT-8061 recall: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting…
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Class II · 1+ years ago
ICU Medical Inc. Smiths Medical CADD Medication Cassette Reservoir with flow stop 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 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.