FDA (Devices) recall action 87696
The FDA (Devices) publishes a recall like this one as 19 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 19 pages.
Products labeled as sterile were distributed, but may not have been 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.
Biopsybell is recalling 305 units of 10 Gauge Single Cement Delivery kits because they were labeled sterile but may not have been sterilized.
Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile but potentially not sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.
BPB medica is recalling Osteobell Explant Needles because they were labeled as sterile but may not have been sterilized.
Biopsybell S.R.L. is recalling CEMIX Cement Mixing Systems labeled as sterile because they may not have been sterilized.
Biopsybell is recalling 160 units of 11G Direct Single Delivery kits because they were labeled as sterile but may not have been sterilized.
Biopsybell is recalling 10G Direct Working Cannulas labeled as sterile because they may not have been sterilized. The recall affects 50 units distributed in Mississippi and Kentucky.
Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.
Biopsybell is recalling 75 units of 11G Direct Working Cannula Diamond Tip Mini because they were labeled sterile but may not have been sterilized.
Biopsybell S.R.L. is recalling 75 units of 10 Gauge Drills labeled as sterile that may not have been sterilized.
Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.
Biopsybell is recalling five Easynject vertebroplasty devices because they were labeled sterile but may not have been sterilized.
Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler labeled as sterile but potentially not sterilized. The product was distributed in Mississippi and Kentucky.
Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.
Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.
Biopsybell S.R.L. is recalling 250 units of 10 Gauge Cement Delivery Cannulas labeled as sterile but potentially not sterilized.
BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.
Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile may not have been sterilized.
Biopsybell is recalling 50 units of 11G Direct Single Access devices labeled as sterile but potentially not sterilized, distributed in Mississippi and Kentucky.
Biopsybell S.R.L. is recalling 330 units of 10G Direct Single Access devices because they were labeled as sterile but may not have been sterilized.