All recalls8,517 total
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
The recall was the result of the firm's routine sampling program and Listeria monocytogenes was detected in an in-process shrimp sample in a food production environment.
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
Overpressurization leading to exploding cans
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
The quantity of product in each unit does not match the stated weight.
Potential for product spoilage (increased level of lactic acid detected in retain samples).
The quantity of product in each unit does not match the stated weight.
Undeclared allergens and mislabeled product. Rocky Road Ice was packaged with Chocolate Truffle Ice Cream labeled tub and a Rocky Road Ice Cream lid. Tub said "may contain tree nuts" the lid said it did contain almonds.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Undeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)
Undeclared Sesame. The firm was notified by a retailer that product labeled as Sea Salt Bagel Crackers contained Everything Bagel Crackers. The Everything Bagel Crackers contains sesame which is not listed in the ingredient statement.
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Marketed Without an Approved NDA/ANDA
Due to a risk of false positive results that could lead to unnecessary medical treatment.
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Presence of a foreign substance: black hair found embedded in tablet.
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
Pseudomonas in Mineral Water. The firm was notified by their distributor that product placed on hold was released and shipped to customers.
Foreign Material (metal)
Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Discoloration; discolored solution from cracked vials
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.