United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC ...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by:...
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog N...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Marquesita de Guava [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUL...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ...
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Rollitos de Guava [image] Guava Rolls The Original, Net Wt. 15 oz, packaged in a...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transpa...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Cheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannu...
The cannulation of the CCS screw is not centered.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUS...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Bicarby Dialysate; Model number: RFP-400-G;
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 and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (U...
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPO...
Due to incorrect incubation process being performed on product.
MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/d...
Potential physical contamination: dark spot was noticed on the bottom of container.
Allia Moveo angiographic X-ray system
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 to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).