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Consumer Product Recalls
127,277 recalls from the U.S. Consumer Product Safety Commission, newest first.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product De
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDI
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 3162
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: Med
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model
Hazard: Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
September 10, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corre
Hazard: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
September 10, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp
Hazard: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
September 10, 2025Medical DevicesFDA
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str
Hazard: Due to products distributed without premarket clearance or approvals.
September 10, 2025Medical DevicesFDA
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str
Hazard: Due to products distributed without premarket clearance or approvals.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000
Hazard: Due to required inspections not being performed on products/units that have gone through servicing.
September 10, 2025Medical DevicesFDA
Medtronic MiniMed, Inc. recalls InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Hazard: 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 insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RaySta
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2.
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStati
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStatio
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatio
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStatio
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A
Hazard: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
September 10, 2025Medical DevicesFDA
Reflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002
Hazard: Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
September 10, 2025Medical DevicesFDA
Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect
Hazard: As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
September 10, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Hazard: The catheters may not retain their shape.
September 10, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Hazard: The catheters may not retain their shape.
September 10, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Hazard: The catheters may not retain their shape.
September 10, 2025Medical DevicesFDA
mo-Vis BVBA recalls IDM-ARLITE-R. Electrical wheelchair component.
Hazard: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.