Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 409–420 of 822 recalls
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
The impacted lot may not meet the required tensile strength specification.
The impacted lot may not meet the required tensile strength specification.
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815).…
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Due to incorrect product label (Incorrect product name identified on outer packaging).
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16.…
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
The nasal feeding tube may be occluded