Reported May 14, 2025 · Ongoing
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Galt Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
- Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
- Lot codes and dates
- Catalog NumberNDL-107-04
- UDI-DI code00841268102729
- Lot Number24108670
- Amount recalled
- 200 needles
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Due to a potential open seal in the sterile barrier packaging.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.