V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 2...
FDA Device Recall #Z-2918-2026 - Class II, June 24, 2026
Recall Summary
| Recall Number | Z-2918-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | June 24, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien, LP |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 135,875 total |
Product Description
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.
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.
Lot / Code Information
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
Other Recalls from Covidien, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2919-2026 | Class II | V-Loc 180 Absorbable Wound Closure Device BO... | Jun 24, 2026 |
| Z-2922-2026 | Class II | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-... | Jun 24, 2026 |
| Z-2920-2026 | Class II | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM ... | Jun 24, 2026 |
| Z-2921-2026 | Class II | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X... | Jun 24, 2026 |
| Z-2281-2026 | Class II | Covidien EndoStitch" Polysorb Single Use Loadin... | Apr 15, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.