Clinic Pack 100 Pieces FG 57 100057C (100057C)
Coltene Whaledent
Class I - Dangerous
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Thomas Scientific
Class I - Dangerous
The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
Class I - Dangerous
The product may be mislabeled.
Strauss 25 Carbide Dental Burs (100057XXV)
Coltene Whaledent
Class I - Dangerous
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Fresenius Medical Care Holdings
Class I - Dangerous
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Hardy Diagnostics
Class I - Dangerous
Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10
Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Merete Medical GmbH
Class I - Dangerous
Product may be mislabeled.
Class I - Dangerous
There is a potential for fire in the inside computer cabinet.
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Merete Medical GmbH
Class I - Dangerous
Product may be mislabeled.
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
Merete Medical GmbH
Class I - Dangerous
Product may be mislabeled.
Class I - Dangerous
The product did not receive pre-market approval or clearance.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.