Lower risk Medical device recall · FDA · Published March 27, 2025

Galt Medical Recalls GALT Guidewire REF SGW-051-0: Potential Packaging Seal Issue

Galt Medical recalls GALT Guidewire REF SGW-051-07 due to potential open seal in sterile packaging. This could compromise sterility during medical procedures.

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

🇺🇸 FDA recall #Z-1734-2025Medical device Galt Medical ›

Lower-risk recall

Due to a potential open seal in the sterile barrier packaging.

Take action

Contact the company

Recalling firmGalt Medical Corporation2220 Merritt Dr · Garland, TX 75041-6137

✎ GovInfoNow plain-language explainer

Galt Medical is recalling GALT Guidewire REF SGW-051-07 because the sterile packaging might have an open seal. This could lead to contamination during medical procedures if the device is used without proper sterility. Read more at govinfonow.com/recall/52522-galt-medical-recalls-galt-guidewire-ref-sgw-051-0-potential.

Source Summary by GovInfoNow · govinfonow.com/recall/52522-galt-medical-recalls-galt-guidewire-ref-sgw-051-0-potential · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1734-2025

Cite this page

“Galt Medical Recalls GALT Guidewire REF SGW-051-0: Potential Packaging Seal Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52522-galt-medical-recalls-galt-guidewire-ref-sgw-051-0-potential. Based on FDA recall #Z-1734-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1734-2025%22&limit=1).

Galt Medical Corporation voluntarily recalled GALT Guidewire REF SGW-051-07 guidewires due to a potential open seal in the sterile barrier packaging, according to the FDA on March 27, 2025.

How to tell if you have it

Brand: Galt Medical
Product: GALT Guidewire REF SGW-051-07 Guidewires
Catalog Number: SGW-051-07
Lot Number: 25050797

The hazard

The guidewires pose a risk due to a potential open seal in the sterile barrier packaging, according to the FDA.

Context

GovInfoNow's records show Galt Medical Corporation has had four other recalls since May 2, 2018. Other recent recalls of similar products include Medline Quick-Strip Bandages Recall: Open Packaging May Compromise Sterility (Oct. 27, 2025), Medline Convenience Kits May Contaminate Patient Due to Open Seals (July 31, 2026), and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).

How to tell if you have this one

Check for the model number SGW-051-07 on the packaging. These guidewires were sold with the lot number 25050797.

Brand
Galt Medical
Category
Medical device

FDA recall event · 7 products

All 7 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 - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-1731-2025	GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.; Catalog Number: DRC-002-05 UDI-DI codes: 00841268100381 Lot Number: 25051843 Catalog Number: DRC-002-06 UDI-DI code: 00841268100398 Lot Number: 25034783	2,881 catheters
Z-1732-2025	B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.; KIT-018-47 UDI-DI code: 0404696432727 Lot Number: S25052261 KIT-019-67 UDI-DI code: 0404696432738 Lot Number: P25052052 KIT-018-41 UDI-DI code: 0404696432750 Lot Number: S25064124 KIT-019-37 UDI-DI code: 0404696432802 Lot Number: P25115062	1,400 dilators
Z-1733-2025	B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.; Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171	100 systems
Z-1734-2025	GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.; Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797	100 guidewires
Z-1735-2025	Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.; Catalog Number: KIT-002-28 UDI-DI code: 00841268104730 Lot Number: G25038156 KIT-002-34, UDI-DI code: 00841268104792 Lot Number: G25064259 KIT-002-35, UDI-DI code: 00841268104808 Lot Number: G25029077 KIT-011-40, UDI-DI code: 00841268105553 Lot Number: S25031227 KIT-011-62, UDI-DI code: 00841268105614 Lot Numbers: G25052163 G25080165 KIT-038-04, UDI-DI code: 00841268104556 Lot Number: G25092186 KIT-039-03, UDI-DI code: 00841268104587 Lot Numbers: G25050190 G25078192 KIT-039-13, UDI-DI code: 00841268106055 Lot Number: G25050202 KIT-081-02 / PS2-38, UDI-DI code: 00841268108394 Lot Number: G25056231	4,280 kits
Z-1736-2025	Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires; Catalog Number: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670	200 needles
Z-1737-2025	Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.; Catalog Number: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447	490 units

Based on the official FDA remedy

What to do — step by step

Check Packaging Seal
Inspect the sterile packaging for any signs of an open seal.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 8 states.

FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, Utah.

Recall timeline

FDA published this recall 48 days after the firm started it.

Mar 27, 2025Firm started the recall
May 7, 2025FDA classified it Class II
May 14, 2025Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/52522-galt-medical-recalls-galt-guidewire-ref-sgw-051-0-potential">Galt Medical Recalls GALT Guidewire REF SGW-051-0: Potential Packaging Seal Issue (GovInfoNow)</a>

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-1734-2025 (March 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1734-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.