Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
USFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Recalling Firm: Erbe USA Inc
Motivo del Retiro / Peligro
TranslatedProbes may rupture/burst during activation
Descripción del Producto e Identificación
TranslatedFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Productos Afectados
TranslatedFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Additional Source Details
| Field | Value |
|---|---|
| City | Marietta |
| State | GA |
| Event id | 98429 |
| Address 1 | 2225 Northwest Pkwy SE |
| Code info | UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial 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 |
| Postal code | 30067-8764 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 3603 units |
| Reason for recall | Probes may rupture/burst during activation |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260212 |
| Initial firm notification | |
| Center classification date | 20260320 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableErbe USA Inc
- StatusOngoing
- Nivel de RiesgoClass I
- DistributionUS Nationwide distribution, including Puerto Rico.
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🚨 SAFETY ALERT: Erbe USA Inc - Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use Check if your household is affected: https://therecallfile.com/es/recalls/flexible-cryoprobe-od-2-4mm-l1-15mm-ref-20402-411-for-surgical-use/FDA-Z-1568-2026
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