United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Cheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, p...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transpare...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27,...
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) ...
Product may be contaminated with Salmonella.
Allia IGS Pulse 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.
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.
Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 3...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 33...
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Halyard, Pain Pack. Kit Code: AMPK48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle...
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, So...
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: ...
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
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).
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules...
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
Cake de Mango [image] Mango Cake The Original, Net Wt. 47 oz, packaged in a rigi...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, ...
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka...
Failed Impurities/Degradations Specifications
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transpa...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
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.
Jumbo Napolitano [image] Jumbo Neapolitan, Net Wt. 26 oz, packaged in a rigid pl...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
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.
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.