June 17, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Plum Solo Precision IV Pump, 40001-0401
Hazard: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
June 17, 2026Medical DevicesFDA
Fresh Roast Systems Inc recalls Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
Hazard: A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.
June 10, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Produc
Hazard: Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
June 10, 2026Medical DevicesFDA
SSC- Surgical Specialties Corporation recalls Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Hazard: 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
June 10, 2026Medical DevicesFDA
Grace Medical, Inc. recalls TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Pro
Hazard: Due to incorrect functional length on device labeling.
June 10, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical AMS16835 Fluids Kit RX
Hazard: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
June 10, 2026Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Hazard: Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
June 10, 2026Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Hazard: Sterile wound dressing, lacks sterility assurance
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis Mini Main REF: 349 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES REF: 323 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 REF: 303 Medication cabinet
Hazard: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
June 10, 2026Medical DevicesFDA
Bayer Medical Care, Inc. recalls Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System
Hazard: Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
June 10, 2026Medical DevicesFDA
Daavlin Distributing Company recalls Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psor
Hazard: Some of the Calibration/Output Certificates had the outputs reversed.
June 10, 2026Medical DevicesFDA
Shimadzu Medical Systems recalls Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-
Hazard: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
June 10, 2026Medical DevicesFDA
Kico Knee Innovation Company recalls Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Bloc
Hazard: The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
June 10, 2026Medical DevicesFDA
Kico Knee Innovation Company recalls Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Bloc
Hazard: The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with
Hazard: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
June 10, 2026Medical DevicesFDA
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI
Hazard: Due to incorrect shelf-life expiration date.