Z-2918-2026Class II

V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436...

Name: Z-2918-2026 V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436...
Creator: Covidien, LP
Published: 2026-06-24
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-06-24 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of 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... on 2026-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2918-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-24
Posted: 2026-08-07
Recalling firm: Medtronic, Inc.
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
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm began notifying consignees on 7/7/26 via email, mail, or electronically. Notices were titled, "URGENT: VOLUNTARY MEDICAL DEVICE RECALL." Customers were informed of the manufacturing nonconformance. If products in scope of this field action have been used in patients under the customer's care, the customer is instructed to monitor for signs of infection or vision issues due to the possibility of biocontamination. Customers were instructed to immediately identify, cease use, and quarantine all unused impacted product. Unused impacted product is to be returned to Medtronic. The recall notice should be passed on to all those who need to be aware within the customer's organization or to any organization where devices have been transferred.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2918-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2918-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2919-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2920-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2921-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2922-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07

Product code GAM

K100257Class IIVloc9absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare / cleared 2010-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)