All Recalls

Levels of iodine exceeding label claim

Presence of Foreign Tablets/Capsules.

Lack of Assurance of Sterility

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

Lack of Assurance of Sterility

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Lack of Assurance of Sterility

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Presence of foreign substance: Presence of Benzene.

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

Lack of Assurance of Sterility

Presence of foreign substance: Presence of Benzene.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Sterility assurance with procedure trays

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.