Class I - Dangerous
Breaking at the point of a welded joint
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
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
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.
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
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
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.
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Class I - Dangerous
Colored contact lenses were distributed without FDA clearance.
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - 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.
TTDEYE (brand) Flower Grey, B16112231 - 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
TTDEYE (brand) Flower Brown, B16112210 - 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
Class I - Dangerous
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Class I - Dangerous
6.0x50mm poly-reduction screws were laser etched 6.0x45