FDA (Devices) recall action 92409
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Firm has received reports of patient burns in surgical procedures where device was used.
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.
Megadyne Medical Products is recalling 21,100 units of MEGA SOFT Universal Plus Patient Return Electrodes used in electrosurgery. The FDA Class I recall follows reports of patient burns during surgical procedures.
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode due to reported patient burns that occurred during electrosurgical procedures.
Megadyne Medical Products is recalling 21,100 MEGADYNE MEGA SOFT Reusable Patient Return Electrodes nationwide due to reports of patient burns during electrosurgical procedures.
Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.
Megadyne Medical Products is recalling 21,100 MEGA SOFT electrosurgery patient return electrodes distributed nationwide due to reports of patient burns during surgical procedures.
Megadyne Medical Products recalls approximately 21,100 MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes (Model 0840) due to reports of patient burns during electrosurgical procedures.
The FDA is recalling 21,100 units of the MEGADYNE MEGA 2000 Patient Return Electrode due to reports of patient burns during electrosurgical procedures. All units distributed nationwide are affected.
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode used in electrosurgery due to reports of patient burns during surgical procedures.