Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
USSurgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Recalling Firm: Covidien, LP
Motif du rappel / Danger
TranslatedProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Description du produit & Identification
TranslatedSurgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Produits concernés
TranslatedSurgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Additional Source Details
| Field | Value |
|---|---|
| City | North Haven |
| State | CT |
| Event id | 99390 |
| Address 1 | 60 Middletown Ave |
| Code info | S8698GX UDI-DI 20612479214716 Lot D5M3438FY |
| Postal code | 06473-3908 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 135,875 total |
| Reason for recall | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260624 |
| Initial firm notification | Letter |
| Center classification date | 20260807 |
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 Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX?
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.
Vérifiez les autres produits de votre foyer
Outils gratuitsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Aperçu
- Entreprise responsableCovidien, LP
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
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🚨 SAFETY ALERT: Covidien, LP - Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX Check if your household is affected: https://therecallfile.com/fr/recalls/surgipro-ii-s8698gx-surgipro-ii-bl-5-0-18-p-13-s8698gx/FDA-Z-2922-2026
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