FDA (Devices) recall action 86807
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.
Potential exposure of product to microbial contamination.
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.
TissueTech, Inc. is recalling 10 units of PROKERA Plus non-sterile biologic corneal bandages due to potential exposure to microbial contamination.
TissueTech, Inc. is recalling 75 units of PROKERA Slim non-sterile biologic corneal bandages due to potential exposure to microbial contamination.
TissueTech, Inc. is recalling 63 units of PROKERA non-sterile biologic corneal bandages due to potential exposure to microbial contamination.