FDA (Devices) recall action 97149
The FDA (Devices) publishes a recall like this one as 24 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 24 pages.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
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.
General Robotic Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 203 units are affected.
Major Thoracoscopy Basin medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 128 units are affected.
GYN Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 346 units are affected.
Robotic Uro/Gyn Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 372 units are affected.
DA VINCI PACK URO/PROSTATE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 21 units affected.
PACK GENERAL ROBOTIC medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 656 units are affected.
HVI Cardiac Robot Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 20 units are affected.
GS Endoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 816 units are affected.
DAVINCI TRUCUSTOM BUNDLE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 626 units are affected.
DAVINCI UROLOGY medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 166 units are affected.
GYN Robotic Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized in the kits, causing discoloration. 45 units affected.
Laparoscopic Tray medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 40 units are affected.
Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 452 units are affected.
Cardiac Robot Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 20 units are affected.
Partial Nephrectomy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 52 units are affected.
LAVH Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 292 units are affected.
Partial Nephrectomy - Robotic medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 46 units affected.
CT DAVINCI medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized in the kits, causing discoloration. 12 units are affected.
Laparoscopic Prostatectomy medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 30 units are affected.
Gen Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 321 units are affected.
Laparoscopic GYN medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 18 units are affected.
General Laparoscopy Tray medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 574 units are affected.
Lap Chole Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 85 units are affected.
ROBOTIC PROSTATECTOMY PACK medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 24 units affected.