FDA (Devices) recall action 73427
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.
Compromised sterility due to breach of barrier
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.
The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.
FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.
Covidien LLC is recalling Vistec X-Ray Detectable Sponges because a breach of the barrier packaging may have compromised sterility.
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.
Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.
FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a breach of the barrier.
FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.