Medical device recalls

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.

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.

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.

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.

Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,

Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.

Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule

The product may be mislabeled.

The product may be mislabeled.

Potential for cleaning solution intrusion into endoscope

The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.

The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.

The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.

The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.

The feeding spike sets may leak at the interface of the tube and spike connector.

The feeding spike sets may leak at the interface of the tube and spike connector.

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm up" mode was not completed after initializing the system when first turned on.

The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

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.

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.

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.

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.

A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.

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

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.