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.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
There are reports of the suction catheter coming apart from the device assembly during use.
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
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Class I - Dangerous
The needle surface deteriorated due to unexpected electrolysis during procedure.
Class I - Dangerous
The needle surface deteriorated due to unexpected electrolysis during procedure.
Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Carefusion 2200
Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Class I - Dangerous
The needle surface deteriorated due to unexpected electrolysis during procedure.
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Becton Dickinson & Company
Class I - Dangerous
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
Becton Dickinson & Company
Class I - Dangerous
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
Class I - Dangerous
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Class I - Dangerous
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
Becton Dickinson & Company
Class I - Dangerous
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.