Medical device recalls

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

There is a potential that valve assemblies will not open. preventing fluid from draining.

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the lock, leading to loss of suspension of the external prosthetic system that replaces a missing lower limb, which can lead to falling and injury.

Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".

The threads on posts stripping out when tensioned during application process.

Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.

Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.

The laser operation might fall under a higher laser class.

Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

The custom procedure packs contain light handle covers that have been recalled by another firm.

The custom procedure packs contain light handle covers that have been recalled by another firm.

Inadvertently released for distibution without sterility assurance.

Potential for the incorrect size stent-graft than the printed carton label.

Some of the ambIT kits were potentially distributed without an air in-line filter.