CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report
GALT Guidewire recalled by Galt Medical
Galt Medical is recalling GALT Guidewire, distributed nationwide in the US. The recall was initiated on 27 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1734-2025
- FDA event ID
- 96622
- Recalling firm
- Galt Medical, Garland, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Mar 2025
- FDA classified
- 7 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 27 Mar 2025 | Recall initiated by company | |
| 7 May 2025 | Classified by FDA | +41 days |
| 14 May 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a potential open seal in the sterile barrier packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaFloridaGeorgiaIllinoisMassachusettsOhioPennsylvaniaUtah
Questions about this recall
Why was it recalled?
Due to a potential open seal in the sterile barrier packaging.
Which lots are affected?
Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 96622| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | B Braun Interventional Coaxial Dilator recalled by Galt Medical | Galt Medical | Sterility | Nationwide | |
| CLASS II | B Braun Interventional Elite HV Hemostasis Valve Introducer System recalled | Galt Medical | Sterility | Nationwide | |
| CLASS II | Introducer Kit- Tearaway MicroSlide recalled by Galt Medical | Galt Medical | Sterility | Nationwide | |
| CLASS II | Introducer Needle recalled by Galt Medical | Galt Medical | Sterility | Nationwide | |
| CLASS II | Introducer Kit- Coaxial Dilator recalled by Galt Medical | Galt Medical | Sterility | Nationwide | |
| CLASS II | GALT Centeze Catheter recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
More recalls from Galt Medical
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | GALT Centeze Catheter recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
| Device | CLASS II | Introducer Kit- Coaxial Dilator recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
| Device | CLASS II | Introducer Needle recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
| Device | CLASS II | Introducer Kit- Tearaway MicroSlide recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |