FDA (Devices) recall action 91953
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
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.
Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
Richard Wolf surgical forceps may fail to open when the endoscope shaft is bent. Affected units distributed worldwide; users should check lot numbers and discontinue use if affected.
Surgical grasping forceps may fail to open when the endoscope shaft is bent, potentially affecting their use during endoscopic procedures.