Covidien Surgipro II surgical sutures recalled over sterility risk
Covidien is recalling certain Surgipro II 5/0 sutures (model S8698GX, lot D5M3438FY) because the sterile packaging may be torn or punctured. This could allow germs into the sutures, which may lead to infection, prolonged surgery, or vision loss when used in eye surgery. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Covidien recalls
What to do
- Check whether your facility or practice has model S8698GX, lot D5M3438FY in stock.
- Do not use affected sutures; follow your facility's recall procedures for quarantine and return.
- Contact Covidien or your supplier with questions about replacement or disposal.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 135,875 total
- Illnesses reported
- None reported
- Manufactured in
- 60 Middletown Ave, North Haven, CT, United States
- Classification
- Class II
- Recall number
- Z-2922-2026
In the FDA's words
- Description
- Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX 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. 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. Affected quantity: 135,875 total
- 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.
5 products in this recall
Covidien surgical sutures recalled for compromised sterile packaging
Covidien is recalling five surgical suture products, including V-Loc 90, V-Loc 180, Dermalon, Surgipro and Surgipro II, with about 135,875 units affected. The sterile packaging may have a tear or hole, which could let germs reach the sutures and cause infection, prolonged surgery, or vision loss if used in eye surgery. The recall covers the US and many other countries, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 C…Z-2918-2026 · 135,875 total
- V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056…Z-2919-2026 · 135,875 total
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31Z-2920-2026 · 135,875 total
- Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Z-2921-2026 · 135,875 total
- Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX (this page)Z-2922-2026 · 135,875 total