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Lower risk Medical device recall · FDA · Published May 8, 2023

Galt Medical Tearaway Introducer Kit Recall: Luer Connection Cracks Risk

Galt Medical recalls Tearaway Introducer Kits with serial numbers KIT-010-12, KIT-010-17, KIT-900-16 due to potential luer connection cracks causing dilator hub dislodgement. Affected kits may require replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1968-2023Medical deviceGalt Medical ›
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Recalling firmGalt Medical Corporation2220 Merritt Dr · Garland, TX 75041-6137
✎ GovInfoNow plain-language explainer

Galt Medical is recalling specific Tearaway Introducer Kits that could have a luer connection portion that cracks or dislodges during use. This might make the dilator component unusable and require a replacement device. Read more at govinfonow.com/recall/58449-galt-medical-tearaway-introducer-kit-recall-luer-connection-cracks-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58449-galt-medical-tearaway-introducer-kit-recall-luer-connection-cracks-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1968-2023

Cite this page

“Galt Medical Tearaway Introducer Kit Recall: Luer Connection Cracks Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58449-galt-medical-tearaway-introducer-kit-recall-luer-connection-cracks-risk. Based on FDA recall #Z-1968-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1968-2023%22&limit=1).

The FDA announced on May 8, 2023, that Galt Medical Corporation is recalling the Tearaway Introducer Kit due to potential luer connection cracks or dislodgement. The agency issued recall number Z-1968-2023 for the Class II device distributed worldwide.

How to tell if you have it

  • Brand: Galt Medical
  • Product: Tearaway Introducer Kit
  • REF: KIT-010-12, KIT-010-17, KIT-900-16
  • Lot codes: S23104607, S22356870, S23083725, S22231321, S22328872, S22308637
  • Expiration dates: 2/05/2027, 1/11/2027, 9/08/2026, 1/18/2027, 1/04/2027

The hazard

According to the FDA, sheath introducer assemblies could have a luer connection portion of the dilator hub that cracks or dislodges during use due to improper storage conditions. This renders the dilator component unusable and can require the use of a replacement device.

Context

GovInfoNow's records show Galt Medical Corporation has 4 other recalls on record since May 2, 2018. Other recent recalls include the Boston Scientific Transcarotid Kit Sheath Depth Markings recall (June 26, 2026), Galt Medical Introducer Needles Recall (March 27, 2025), and Galt Medical Centeze Catheter Recall (Nov. 16, 2020). Other recent recalls of similar products include Stryker Hoffmann II Connecting Rod Micro 3 x 50mm (July 1, 2026), Medline Convenience Kits Recall (April 27, 2026), and Medline Medical Kits Recall (Feb. 27, 2026).

How to tell if you have this one

Check for serial numbers KIT-010-12, KIT-010-17, or KIT-900-16 on the kit. The kits have specific expiration dates listed in the recall notice.

  • Brand
    Galt Medical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.
Recall numberProduct, codes & lotsQuantity
Z-1968-2023Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16; REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027), S22356870(1/11/2027); KIT-010-17/00841268105249/S23083725(2/05/2027), S22231321(9/08/2026), S22328872(1/18/2027); KIT-900-16/S22308637(1/04/2027)490
Z-1969-2023Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk); REF/UDI-DI/LOT (Expiration): INT-028-27 (OEM)/22136556(2/28/2026); INT-105-25/00841268101845/23032145(12/28/2026), 22339238(10/03/2026), 22266856(8/25/2026), 23132602(4/04/2027), 23019935(12/13/2026), 22182660(6/13/2026); INT-106-09/00841268102156/23033942(12/28/2026), 22335239(10/03/2026), 22112754(3/14/2026), 21313293(11/11/2021), 21148681(5/03/2025), 22203491(7/07/2026), 21330748(10/27/2025), 21232023(8/02/2025), 22280971(8/30/2026); INT-106-12/00841268102187/23068151(2/21/2027); INT-106-17/00841268102231/23033947 (12/06/2026), 23167613(4/03/2027); DSS-007-04 (bulk)/PRCGM047382; DSS-007-05 (bulk)/PRCGM050270; DSS-010-065 (bulk)/PRCGM040042; DSS-012-07 (bulk)/PRCGM039532, PRCGM0390966036
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Serial Numbers

    Identify the kit's serial number from the product label to determine if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Georgia, Massachusetts, Nevada, New Jersey, New York, Ohio, Pennsylvania, Utah.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: May 8, 202312. FDA classified it Class II: Jun 15, 202323. Published in FDA’s Enforcement Report: Jun 21, 202332023
  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-1968-2023 (May 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1968-2023 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