Summary
The FDA issued a Class II for Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 by Covidien, LP. Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which ma.
Details
Source
Device Recall
External ID
Z-2921-2026
Action Date
2026-08-19
Status
Ongoing
Category
device
Product Description
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Lot/Code Info: SP-623 UDI-DI 20884521037073 Lot D6A2963Y
Quantity Affected: 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-24
Company
North Haven, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 376 device-related FDA actions this month.
Covidien, LP has 95 FDA actions in our database, including 94 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 95 FDA actions in our database, including 94 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2921-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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