Mozarc Medical US Mahurkar Elite PASS Trays recall — FDA Z-2319-2026
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock…
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Presence of Particulate matter: Particulate matter identified as glass.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Contains undeclared allergen (shrimp).
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Browse recent months with enough recall history for useful comparison.