FDA (Devices) recall action 98429
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.
Probes may rupture/burst during activation
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.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-411 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-410 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-401 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.