Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
USProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Recalling Firm: Olympus Corporation of the Americas
Motivo del Retiro / Peligro
TranslatedDevices which did not undergo thermoforming could deform and lose performance.
Descripción del Producto e Identificación
TranslatedProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Productos Afectados
TranslatedProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98252 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model/Catalog Number: KD-411Q-0730; Material REFs: (1) 5858230, (2) N6221731, (3) N6221740; UDI-DI: (1)04953170466557, (2)04953170466557, (3)04953170466557; All Lots with a valid expiration date |
| Postal code | 18034-8229 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 887 units (650 US, 237 OUS) |
| Reason for recall | Devices which did not undergo thermoforming could deform and lose performance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | Letter |
| Center classification date | 20260205 |
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 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These in...?
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 ResponsableOlympus Corporation of the Americas
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.
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🚨 SAFETY ALERT: Olympus Corporation of the Americas - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Check if your household is affected: https://therecallfile.com/es/recalls/product-name-disposable-triple-lumen-sphincterotome-model-catalog-numb/FDA-Z-1286-2026
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