🏥 Medical Devices Class I - Dangerous
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
All Recalls
95,018 total recalls in our database
The Oncology Essentials Package of the Spectral CT imaging system.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
Potential interference with the anti-fall system.
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Allergan Sales
🏥 Medical Devices Class I - Dangerous
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0544CJDA
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
🏥 Medical Devices Class I - Dangerous
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
IVOCLAR VIVADENT AG
🏥 Medical Devices Class I - Dangerous
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.