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Stop using now Medical device recall · FDA · Published May 3, 2022

Conmed Gastrobypass Needle Recall: Risk of Electrode Detachment

Conmed recalls gastrobypass needles with potential electrode detachment during use. Affected items include specific model numbers and lot dates. Stop using immediately to prevent injury.

🇺🇸 FDA recall #Z-1250-2022Medical deviceROi CPS ›
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Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
✎ GovInfoNow plain-language explainer

What happened, in plain English

Conmed is recalling gastrobypass needles that may detach the electrode during use, which could cause injury. This recall affects specific model numbers and lot dates produced between 2023 and 2024. Read more at govinfonow.com/recall/60735-conmed-gastrobypass-needle-recall-risk-of-electrode-detachment.

Source Summary by GovInfoNow · govinfonow.com/recall/60735-conmed-gastrobypass-needle-recall-risk-of-electrode-detachment · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1250-2022

Cite this page

“Conmed Gastrobypass Needle Recall: Risk of Electrode Detachment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60735-conmed-gastrobypass-needle-recall-risk-of-electrode-detachment. Based on FDA recall #Z-1250-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1250-2022%22&limit=1).

Why it’s dangerous

The electrode tip may detach during use, potentially causing injury to the patient. This could happen during the procedure if the needle is not securely attached.

Who’s affected

Patients using the Conmed gastrobypass needles with the specified model numbers and lot dates are affected. Medical professionals performing procedures with these needles are at highest risk.

How to tell if you have this one

Check for model number GS00367G, lot numbers 88207G through 91105, and expiration dates from May 2023 to January 2024. The product is sold under Conmed's catalog numbers.

  • Brand
    ROi CPS
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discontinue use of the recalled gastrobypass needles to prevent potential electrode detachment and injury.

Where it went and when

Where it was distributed

Distributed in North Carolina.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distributed to North Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: North Carolina.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: May 3, 202212. FDA classified it Class II: Jun 8, 202223. Published in FDA’s Enforcement Report: Jun 15, 202234. FDA terminated the recall: May 31, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What lot numbers are affected?

Lot numbers 88207G, 88396G, 88472G, 88965G, and 91105 are affected.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1250-2022 (May 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1250-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA