🏥 Medical Devices Class I - Dangerous
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
🏥 Medical Devices Class I - Dangerous
There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.
🏥 Medical Devices Class I - Dangerous
Breaking at the point of a welded joint
🏥 Medical Devices Class I - Dangerous
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
🏥 Medical Devices Class I - Dangerous
One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Shanghai United Imaging Healthcare Co.
🏥 Medical Devices Class I - Dangerous
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
🏥 Medical Devices Class I - Dangerous
Breaking at the point of a welded joint
🏥 Medical Devices Class I - Dangerous
There are reports of the suction catheter coming apart from the device assembly during use.
🏥 Medical Devices Class I - Dangerous
Tube material of a smaller diameter was used.
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
🏥 Medical Devices Class I - Dangerous
Colored contact lenses were distributed without FDA clearance.
🏥 Medical Devices Class I - Dangerous
The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
Resource Optimization & Innovation
🏥 Medical Devices Class I - Dangerous
The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
🏥 Medical Devices Class I - Dangerous
Screws provided in packaging are 5mm shorter than intended
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Shanghai United Imaging Healthcare Co.
🏥 Medical Devices Class I - Dangerous
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
🏥 Medical Devices Class I - Dangerous
Breaking at the point of a welded joint
🏥 Medical Devices Class I - Dangerous
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Abbott Gmbh & Co. KG
🏥 Medical Devices Class I - Dangerous
Quality Control results were not properly evaluated for QC failures.
TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
🏥 Medical Devices Class I - Dangerous
Colored contact lenses were distributed without FDA clearance.
🏥 Medical Devices Class I - Dangerous
Breaking at the point of a welded joint