Z-2922-2026 Class II Ongoing

Recalled by Covidien, LP — North Haven, CT

FDA device recall Z-2922-2026 was initiated by Covidien, LP on June 24, 2026 and is designated Class II. 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 ophthalm… The recall status is ongoing. Affected quantity: 135,875 total.

Recall Details

Product Type
Devices
Report Date
August 19, 2026
Initiation Date
June 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
135,875 total

Product Description

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

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.

Distribution Pattern

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.

Code Information

S8698GX UDI-DI 20612479214716 Lot D5M3438FY