Reported Apr 1, 2026 · Ongoing
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Erbe USA Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Erbe USA Inc · 2225 Northwest Pkwy SE · Marietta, GA · 30067-8764
Is this the product you have?
Flexible Cryoprobe (OD 1.1mmL1.15mm) w/ oversheath (OD2.6mm
- L817mm) REF20402-401 STERILE EO. For surgical use
- Lot codes and dates
- UDI04050147021785/
- Expanded Lots
165 of 165 codes
WO471345WO471346WO471347WO471348WO471349WO472537WO472538WO472539WO472540WO472594WO472595WO472596WO472597WO472598WO472599WO472600WO472601WO472602WO472603WO472617WO472618WO472619WO472620WO472621WO472622WO472623WO472624WO472625WO472626WO472627WO472628WO472629WO472630WO472631WO472632WO472633WO472634WO472635WO472636WO472642WO472643WO472644WO472647WO472648WO472649WO473613WO473614WO473615WO473616WO473617WO473618WO473619WO473646WO473647WO473648WO473649WO473650WO473651WO474289WO474290
- WO478954 WO478955 WO478957 Initial Lots
253 of 253 codes
WO461310WO461311WO461312WO461314WO461315WO461829WO461831WO461832WO461833WO461834WO461835WO461842WO461843WO461844WO461847WO461848WO462117WO462118WO462119WO462120WO462121WO462122WO462123WO462124WO462125WO462128WO462129WO462130WO462373WO462374WO462375WO462376WO462377WO462378WO462379WO462380WO462387WO462388WO462389WO462397WO462825WO462826WO462827WO462828WO462829WO462830WO462831WO462838WO462839WO462840WO462841WO462842WO462843WO462844WO462845WO462846WO462847WO462848WO462849WO463308
- Amount recalled
- 64216 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Probes may rupture/burst during activation
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Erbe USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.