FDA (Devices) recall action 87866
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.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
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.
Meta C.G.M. Spa recalls 27 units of REF 4890 SMARTSCRAPER oral surgery instruments distributed in Texas and Florida. The sterile-labeled devices may not have been adequately sterilized.
Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scrapers distributed in Texas and Florida due to sterility concerns. The single-use sterile devices may not have been adequately sterilized.
Meta C.G.M. is recalling 150 units of SAFESCRAPER TWIST oral surgery instruments distributed in Texas and Florida due to sterility defects. Single-use sterile devices may not have been adequately sterilized, creating a risk of infection.
Meta C.G.M. Spa is recalling MICROSS oral surgery devices due to sterility concerns. Units labeled as sterile may not have been adequately sterilized.