Device recall

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

FDA recall source

Recall number

Z-2921-2026

Event id

99390

Status

Ongoing

FDA classification

Class II

Recalling firm

Covidien, LP

Report date

Aug 19, 2026

Initiated

Jun 24, 2026

Center classification date

Aug 7, 2026

Reason

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.

Quantity

135,875 total

Code info

SP-623 UDI-DI 20884521037073 Lot D6A2963Y

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.

Voluntary or mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States