Class I - Dangerous
Breaking at the point of a welded joint
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
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.
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.
Class I - Dangerous
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Class I - Dangerous
Breaking at the point of a welded joint
Class I - Dangerous
There are reports of the suction catheter coming apart from the device assembly during use.
Tube material of a smaller diameter was used.
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Class I - Dangerous
Colored contact lenses were distributed without FDA clearance.
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
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.
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.
Class I - Dangerous
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Class I - Dangerous
Breaking at the point of a welded joint
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
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.
Class I - Dangerous
Colored contact lenses were distributed without FDA clearance.
Class I - Dangerous
Breaking at the point of a welded joint
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.
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Class I - Dangerous
Colored contact lenses were distributed without FDA clearance.
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Class I - Dangerous
Colored contact lenses were distributed without FDA clearance.