Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA...
FDA Device Recall #Z-0200-2023 — Class II — September 28, 2022
Recall Summary
| Recall Number | Z-0200-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 28, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien, LP |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 117978 |
Product Description
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
Reason for Recall
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Canada Canary Islands Chile Croatia Cyprus Denmark Egypt Finland France Germany Greece Hungary Ireland Israel Italy Jordan Kazakhstan Kuwait Lithuania Luxembourg Mexico Netherlands New Zealand Norway Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
Lot / Code Information
Model VLOCA004L UDI-DI: 20884521068084 Lots N1G0268Y N9M0756Y Model VLOCA006L UDI-DI: 20884521068091 Lots N0D0586Y N0H0178Y N1A0817Y N1B0531Y N1E0104Y N1E0747Y N1F0714Y N1H0583Y N1J0848Y N2D0068Y N2D0077Y N2D0240Y Model VLOCA008L UDI-DI: 20884521068275 Lots N0A0577Y N0C0316Y N0D0001Y N0D0106Y N0D0397Y N0D0398Y N0E0682Y N0F0368Y N0F0758Y N0F0969Y N0G0972Y N0J1022Y N0J1023Y N0K0723Y N0K1031Y N0L0127Y N0L0128Y N0M0360Y N0M0513Y N1A0199Y N1A0660Y N1A0816Y N1A0958Y N1B0110Y N1B0750Y N1C0088Y N1C0398Y N1C0495Y N1D0528Y N1D0697Y N1D0853Y N1E0102Y N1E0103Y N1F0035Y N1F0182Y N1G0107Y N1G0404Y N1G0628Y N1H0234Y N1H0677Y N1J0440Y N1K0248Y N1K0306Y N1K0867Y N1L0592Y N1L0766Y N1M0720Y N1M0731Y N2A0468Y N2B0095Y N2B0188Y N2B0289Y N2C0008Y N2C0009Y N2C0032Y N2C0495Y N2C0683Y N2D0813Y N2D0814Y N9K1167Y N9K1169Y N9L0102Y N9L0103Y N9L0503Y N9L0966Y N9M0077Y Model VLOCA204L UDI-DI: 20884521068114 Lots N0C0212Y N0J0294Y Model VLOCA206L UDI-DI: 20884521068121 Lots N0C0307Y N0D0105Y N0D0326Y N0D0327Y N0D0587Y N0E0718Y N0E0979Y N1A0502Y N1E0748Y N1F0701Y N1F0915Y N1G0759Y N1H0058Y N1H0803Y N1K0185Y N1M0276Y N2C0524Y N2D0233Y N2D0444Y N2D0445Y Model VLOCA208L UDI-DI: 20884521068282 Lots N0A0201Y N0C1103Y N0D0498Y N0D0506Y N0F0759Y N0G0279Y N0G0280Y N0H0960Y N0K0671Y N0K0672Y N0M0315Y N0M0393Y N1A0156Y N1A0501Y N1B0084Y N1B0263Y N1B0560Y N1C0728Y N1E0462Y N1E0508Y N1F0048Y N1F0556Y N1G0123Y N1G0442Y N1H0056Y N1H0257Y N1H0666Y N1H0901Y N1J0216Y N1J0510Y N1J0850Y N1K0164Y N1L0069Y N1L0494Y N1L0672Y N2A0110Y N2B0148Y N2E0299Y N9K1182Y N9L0093Y N9L0502Y N9L0737Y N9L0738Y N9L0761Y N9M0758Y Model VLOCA304L UDI-DI: 20884521068138 Lots N0B0409Y N0D0405Y N0F1041Y N0J0293Y Model VLOCA306L UDI-DI: 20884521068152 Lots N0A0239Y N0A0527Y N0F0833Y N0H1087Y N1F0811Y N1G0287Y N1G0763Y N1K0247Y N2B0322Y N2C0682Y N2D0302Y N2D0552Y N9J0258Y N9M0757Y Model VLOCA308L UDI-DI: 20884521068787 Lots N0A0383Y N0K0988Y N1G0106Y N1G0551Y N1L0085Y N1L0162Y N2C0509Y
Other Recalls from Covidien, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2281-2026 | Class II | Covidien EndoStitch" Polysorb Single Use Loadin... | Apr 15, 2026 |
| Z-0485-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Inte... | Sep 25, 2025 |
| Z-0486-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Inte... | Sep 25, 2025 |
| Z-1891-2024 | Class II | Tri-Staple 2.0 Black Reinforced Intelligent Rel... | Apr 15, 2024 |
| Z-1470-2024 | Class II | Covidien Auto Suture" Blunt Tip Trocar, Product... | Feb 28, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.