Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L,…
Medical device recall Z-0201-2023. Published in FDA’s Enforcement Report on Nov 23, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 23, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 30658 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
30658, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model VLOCN004L UDI-DI: 20884521072579 Lot N0B0834Y Model VLOCN006L UDI-DI: 20884521068824 Lots N0B0660Y N0J0042Y N0J0896Y N1A0931Y N1C0644Y N1L0438Y N2E0205Y N2E0350Y Model VLOCN008L UDI-DI: 20884521073606 Lots N0B0787Y N0E0302Y N1C0706Y…
Every code shown here, 816 characters
Model VLOCN004L UDI-DI: 20884521072579 Lot N0B0834Y Model VLOCN006L UDI-DI: 20884521068824 Lots N0B0660Y N0J0042Y N0J0896Y N1A0931Y N1C0644Y N1L0438Y N2E0205Y N2E0350Y Model VLOCN008L UDI-DI: 20884521073606 Lots N0B0787Y N0E0302Y N1C0706Y N1G0856Y Model VLOCN204L UDI-DI: 20884521072609 Lots N0B0001Y N0E0552Y N0G0568Y N0J0894Y Model VLOCN206L UDI-DI: 20884521068831 Lots N0B0957Y N0G0569Y N0J0933Y N0L0198Y N0M0714Y N1A0932Y N1C0558Y N1C0770Y N1F0047Y N1F0796Y N1G0758Y N1K0184Y N2E0270Y N2E0298Y N9L0954Y Model VLOCN208L UDI-DI: 20884521073774 Lots N0B0772Y N0E0990Y N0G0570Y N0J0870Y N1C0557Y N1F0109Y N1F0132Y N1G0101Y N1J0032Y Model VLOCN304L UDI-DI: 20884521072616 Lots N0B0833Y N0G0487Y Model VLOCN306L UDI-DI: 20884521072654 Lots N0B0851Y N0E0558Y N0G0719Y Model VLOCN308L UDI-DI: 20884521073811 Lot N0G0324Y
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 28, 2022.
- FDA classified it on Nov 11, 2022.
- FDA’s Enforcement Report published it on Nov 23, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien, LP, of North Haven, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.