Covidien, LP recalls V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22VLOCL2246UDI-DI 00199150037902147 affected lots0233506453023350645402335064550233506456BOX07405V1007630009601860233617676BOX01056V2
+139 more
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
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2919-2026
- FDA 510(k) clearance · K091087The device's official FDA premarket clearance record
- FDA 510(k) clearance · K093408The device's official FDA premarket clearance record
- FDA device classification · GAMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4493The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Covidien, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) BASIC PACK
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Eye Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Orthopedic Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Neurological Tray
- Nonconforming Material/Component
