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FDAFDA recall Z-2918-2026 · Aug 19, 2026

Covidien, LP: V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G recall

Recall found

Product

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 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification
Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status
Ongoing
Codes, lots and dates
VLOCM0336 UDI-DI 20884521132501 Lot A5M0917VY VLOCM0436 UDI-DI 20884521827513 Lot A5M1035VY VLOCM0003 UDI-DI 10884521131606 Lot A5M1022VFY UDI-DI 20884521131603 Lots A5M1022VFY A5M1166VFY VLOCM0013 UDI-DI 10884521131644 Lot A5M1024VFY UDI-DI 20884521131641 Lots A5M1023VFY A5M1024VFY VLOCM0024 UDI-DI 10884521131699 Lot A5M0860VFY UDI-DI 20884521131696 Lot A5M0860VFY VLOCM0123 UDI-DI 20884521132235 Lot A5M1169VFY VLOCM0315 UDI-DI 20884521132464 Lot A6A1005VY VLOCM0603 UDI-DI 10884521132535 Lot A5M1246VY UDI-DI 20884521132532 Lot A5M1246VY VLOCM0604 UDI-DI 10884521132542 Lot A5M1062VY UDI-DI 20884521132549 Lots A5M1014VY A5M1062VY VLOCM1203 UDI-DI 10884521132757 Lot A6A1063VY UDI-DI 20884521132754 Lot A6A1063VY VLOCM2115 UDI-DI 20884521133003 Lot A5M1155VY
Quantity
135,875 total
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.
Recalling firm
Covidien, LP, North Haven, CT
Voluntary or mandated
Voluntary: Firm initiated
Recall started
2026-06-24

Source: openFDA enforcement record Z-2918-2026 · search recall number Z-2918-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.

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