FDA (Devices) recall action 92915
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.
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.
3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.
3M is recalling 77,280 Attest biological indicators due to caps that may melt, deform, or crack during steam sterilization cycles, potentially compromising process validation.
3M is recalling specific lots of Attest biological indicators used in steam sterilization monitoring. Certain lots have caps that may melt, deform, or crack at sterilization temperatures of 132°C and 135°C, potentially compromising sterilization process verification.
3M is recalling 172,464 units of Attest biological indicators used to validate steam sterilization because caps may melt, deform, or crack during sterilization at 132°C and 135°C.