Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
USFlexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Recalling Firm: Erbe USA Inc
Grund für den Rückruf / Gefahr
TranslatedProbes may rupture/burst during activation
Produktbeschreibung & Identifikation
TranslatedFlexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Betroffene Produkte
TranslatedFlexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Additional Source Details
| Field | Value |
|---|---|
| City | Marietta |
| State | GA |
| Event id | 98429 |
| Address 1 | 2225 Northwest Pkwy SE |
| Code info | UDI: 04050147021785/ Expanded Lots: WO471345 WO471346 WO471347 WO471348 WO471349 WO472537 WO472538 WO472539 WO472540 WO472594 WO472595 WO472596 WO472597 WO472598 WO472599 WO472600 WO472601 WO472602 WO472603 WO472617 WO472618 WO472619 WO472620 WO472621 WO472622 WO472623 WO472624 WO472625 WO472626 WO472627 WO472628 WO472629 WO472630 WO472631 WO472632 WO472633 WO472634 WO472635 WO472636 WO472642 WO472643 WO472644 WO472647 WO472648 WO472649 WO473613 WO473614 WO473615 WO473616 WO473617 WO473618 WO473619 WO473646 WO473647 WO473648 WO473649 WO473650 WO473651 WO474289 WO474290 WO474291 WO474292 WO474580 WO474581 WO474582 WO474583 WO474584 WO474585 WO474586 WO474587 WO474588 WO475359 WO475360 WO475361 WO475362 WO475363 WO475364 WO475368 WO475369 WO475370 WO475371 WO475372 WO475373 WO475374 WO475375 WO475376 WO475377 WO475378 WO475382 WO475383 WO475384 WO475385 WO475386 WO476017 WO476018 WO476019 WO476020 WO476021 WO476226 WO476227 WO476228 WO476229 WO476230 WO476231 WO476232 WO476233 WO476234 W... [TRUNCATED] |
| Postal code | 30067-8764 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 64216 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 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. 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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Übersicht
- Rückrufendes UnternehmenErbe USA Inc
- StatusOngoing
- RisikostufeClass I
- DistributionUS Nationwide distribution, including Puerto Rico.
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🚨 SAFETY ALERT: Erbe USA Inc - Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use Check if your household is affected: https://therecallfile.com/de/recalls/flexible-cryoprobe-od-1-1mm-l1-15mm-w-oversheath-od2-6mm-l817mm-ref-20/FDA-Z-1566-2026
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