FDA-Device2026-04-01Class I
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Erbe USA Inc
Hazard
Probes may rupture/burst during activation
Sold states
US Nationwide distribution, including Puerto Rico.
Affected count
2408 units
Manufactured in
2225 Northwest Pkwy SE, Marietta, GA, United States
Products
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2026Original summary
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use Probes may rupture/burst during activation UDI: 04050147021846/ Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863 Distribution: US Nationwide distribution, including Puerto Rico. Affected quantity: 2408 units
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief