All recalls7,877 total
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
May be contaminated with fluid from a reach truck
Product has a misbranded Yellow Color. Identified on label at Artificial Yellow Color , and it should be identified as FD&C Yellow #5
Potential contamination with Salmonella.
Clostridium botulinum (uneviscerated fish)
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
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.