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Lower risk Medical device recall · FDA · Published May 14, 2024

Applied Medical Technology AMT Initial Placement Dilator Set Recall: Incorrect Guidewire

Applied Medical Technology recalls AMT Initial Placement Dilator Sets used for gastrostomy placement due to incorrect guidewire labeling. This may cause misplacement of devices.

🇺🇸 FDA recall #Z-2238-2024Medical deviceApplied Medical Technology ›
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Recalling firmApplied Medical Technology Inc8006 Katherine Blvd · Brecksville, OH 44141-4202
✎ GovInfoNow plain-language explainer

Applied Medical Technology is recalling its AMT Initial Placement Dilator Sets for gastrostomy device placement because they have incorrect guidewire labeling. This could lead to improper device placement if used without proper guidance. Read more at govinfonow.com/recall/55118-applied-medical-technology-amt-initial-placement-dilator-set-recall-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/55118-applied-medical-technology-amt-initial-placement-dilator-set-recall-incorrect · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2238-2024

Cite this page

“Applied Medical Technology AMT Initial Placement Dilator Set Recall: Incorrect Guidewire.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55118-applied-medical-technology-amt-initial-placement-dilator-set-recall-incorrect. Based on FDA recall #Z-2238-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2238-2024%22&limit=1).

The FDA announced on May 14, 2024, that Applied Medical Technology Inc is recalling the AMT Initial Placement Dilator Set due to incorrect guidewire labeling. The agency issued recall number Z-2238-2024 for the Class II device.

How to tell if you have it

  • Brand: Applied Medical Technology
  • Product: AMT Initial Placement Dilator Set
  • Model No: IP-DIL
  • UDI-DI: 00842071131876
  • Lot number: 231218-242
  • Exp. Date: 2026-11-01

The hazard

The devices were labeled with incorrect guidewire labeling, according to the FDA. The recall involves 74 units distributed nationwide in Georgia, Illinois, Indiana, Louisiana, North Carolina, Nebraska, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia.

Context

GovInfoNow's records show Applied Medical Technology Inc has four other recalls on record since November 10, 2020. Other recent recalls of similar products include XTANT Medical Xpress Pedicle Screw System (February 18, 2026), Medtronic Octopus 4 Tissue Stabilizer Model 29400 Recall (May 12, 2026), and W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (May 22, 2026).

How to tell if you have this one

Check for model number IP-DIL on the product. The lot number is 231218-242 and expiration date is November 1, 2026. These sets were sold for gastrostomy device placement.

  • Brand
    Applied Medical Technology
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Labeling

    Verify the guidewire labeling on the product to ensure it matches the correct specifications.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: named in the noticeUTColorado: nationwideCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Georgia, Illinois, Indiana, Louisiana, Nebraska, North Carolina, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 57 days after the firm started it.

1. Firm started the recall: May 14, 202412. FDA classified it Class II: Jun 28, 202423. Published in FDA’s Enforcement Report: Jul 10, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-2238-2024 (May 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2238-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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