Ohio recalls

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Incomplete seals on sterile product

Out-of-specification endotoxin result that did not meet the acceptance criteria.

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

Product has the potential for false positive results

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Due to nonconforming products being inadvertently distributed.

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.