Endo Stitch V-Loc PBT Non-Absorbable Reload — Class II medical device recall Z-0201-2023
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-0201-2023 |
|---|---|
| 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 | 30,658 |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 20884521068824, 20884521068831, 20884521072579, 20884521072609, 20884521072616, 20884521072654, 20884521073606, 20884521073774, 20884521073811 |
| Lot numbers | N0B0001Y, N0B0660Y, N0B0772Y, N0B0787Y, N0B0833Y, N0B0834Y, N0B0851Y, N0B0957Y, N0E0302Y, N0E0552Y, N0E0558Y, N0E0990Y, N0G0324Y, N0G0487Y, N0G0568Y, N0G0569Y, N0G0570Y, N0G0719Y, N0J0042Y, N0J0870Y, N0J0894Y, N0J0896Y, N0J0933Y, N0L0198Y, N0M0714Y, N1A0931Y, N1A0932Y, N1C0557Y, N1C0558Y, N1C0644Y, N1C0706Y, N1C0770Y, N1F0047Y, N1F0109Y, N1F0132Y, N1F0796Y, N1G0101Y, N1G0758Y, N1G0856Y, N1J0032Y and 7 more |
| Model numbers | VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L |
Product
Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
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-0201-2023. 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.