Endo Stitch V-Loc 180 Absorbable Reload — Class II medical device recall Z-0200-2023
Ongoing recall by Covidien, LP, reported 2022-11-23, distributed nationwide. Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) inclu
| Recall number | Z-0200-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2022-09-28 |
| Classified | 2022-11-11 |
| Reported by FDA | 2022-11-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CY, DE, DK, EG, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JO, KW, LT, LU, MX, NL, NO, NZ, PL, PT, QA, RO, SA, SE, SK, TR, ZA |
| Quantity | 117,978 |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 20884521068084, 20884521068091, 20884521068114, 20884521068121, 20884521068138, 20884521068152, 20884521068275, 20884521068282, 20884521068787 |
| Lot numbers | N0A0201Y, N0A0239Y, N0A0383Y, N0A0527Y, N0A0577Y, N0B0409Y, N0C0212Y, N0C0307Y, N0C0316Y, N0C1103Y, N0D0001Y, N0D0105Y, N0D0106Y, N0D0326Y, N0D0327Y, N0D0397Y, N0D0398Y, N0D0405Y, N0D0498Y, N0D0506Y, N0D0586Y, N0D0587Y, N0E0682Y, N0E0718Y, N0E0979Y, N0F0368Y, N0F0758Y, N0F0759Y, N0F0833Y, N0F0969Y, N0F1041Y, N0G0279Y, N0G0280Y, N0G0972Y, N0H0178Y, N0H0960Y, N0H1087Y, N0J0293Y, N0J0294Y, N0J1022Y and 132 more |
| Model numbers | VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0200-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.