FDA (Devices) recall action 64888
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Due to lack of sterilization.
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.
Clorox Healthcare Holdings is recalling 1,032,700 units of PSS Select Biopsy Punches because they were not sterilized. The products were distributed nationwide and in Canada, Mexico, and New Zealand.
Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.
Clorox Healthcare Holdings is recalling HealthLink Biopsy Punches because they were not sterilized. The recall affects 1,044,600 units distributed in the US, Canada, Mexico, and New Zealand.