FDA (Devices) recall action 80837
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
The back cap separates from the body of the vitrectomy cutter.
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.
Bausch + Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body.
Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.
Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body.
Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body during use.
Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body.
Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body.
Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.
Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the body of the device.
Bausch & Lomb is recalling Stellaris Elite 20 GA Vit Cutters because the back cap may separate from the body of the device.
Bausch & Lomb is recalling Stellaris Elite vit cutters because the back cap may separate from the body. The defect poses a risk of harm during use.
Bausch + Lomb is recalling Stellaris Elite Vit Cutters because the back cap can separate from the cutter body.
Bausch + Lomb is recalling Stellaris Elite 20 GA Vit Cutters because the back cap may separate from the cutter body.
Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body during use.