Lack of Assurance of Sterility
All Recalls
95,018 total recalls in our database
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.
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
MEDLINE INDUSTRIES, LP - Northfield
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.
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
American Contract Systems
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.
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
MEDLINE INDUSTRIES, LP - Northfield
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.
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
MEDLINE INDUSTRIES, LP - Northfield
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.
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Baxter Healthcare
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Baxter Healthcare
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Baxter TruSystem 7500, Product Code 4091000
Baxter Healthcare
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.