FDA Device recall Z-0200-2023
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLO…
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLO… by Covidien, citing 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 n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0200-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-28 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
Reason
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.
Identifiers
| code_info | Model VLOCA004L UDI-DI: 20884521068084 Lots N1G0268Y N9M0756Y Model VLOCA006L UDI-DI: 20884521068091 Lots N0D0586Y N0H…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 N0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0200-2023%22
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