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
Reason for Recall / Hazard
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.
Product Description & Identification
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Affected Products
Surgipro 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 |
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Overview
- Recalling FirmCovidien, LP
- StatusOngoing
- Risk LevelClass 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/recalls/surgipro-ii-s8698gx-surgipro-ii-bl-5-0-18-p-13-s8698gx/FDA-Z-2922-2026
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