Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX: recall status

Notice names this product. Covidien’s Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX is named in FDA Class II recall Z-2922-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Identifying details: S8698GX UDI-DI 20612479214716 Lot D5M3438FY. Units affected: 135,875 total. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Company / brand: Covidien
Lot / serial / date codes: S8698GX UDI-DI 20612479214716 Lot D5M3438FY
Distribution: US 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.

Agency product description and boundaries

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Covidien

Recalls naming this model

FDA Class II · Medical device · August 19, 2026

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall — Covidien, LP

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 v…

Company / brand: Covidien

Affected product: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Official ID Z-2922-2026 · Official record ↗

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.