FDA (Devices) recall action 78058
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Products may not meet specifications due to possible presence of metal shavings.
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.
Molnlycke Health Care is recalling 204 units of 9x15" Medium Utility Positioners because they may contain metal shavings.
Molnlycke Health Care is recalling 960 units of 7x10" Small Utility Positioners because they may contain metal shavings.