FDA (Devices) recall action 98530
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline is recalling the Anterior Hip Pack because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling the Airway Exam Kit because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling BAL and ENDO kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling three bronchoscopy convenience kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling Thoracic Robots kits, model DYNJ908777B, because they contain recalled Olympus biopsy valves where rubber fragments may detach from the valve slit.
Medline is recalling six bronchoscopy and thoracic kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling four bronchoscopy and laryngoscopy kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.