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Galt Medical Corporation FDA Recalls
10 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , StiClass IIJun 26, 2026Black depth markings may detach from the outer sheath of the |
| B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HVClass IIMar 27, 2025Due to a potential open seal in the sterile barrier packagin |
| GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position Class IIMar 27, 2025Due to a potential open seal in the sterile barrier packagin |
| B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-IntroduceClass IIMar 27, 2025Due to a potential open seal in the sterile barrier packagin |
| Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 0084126810480Class IIMar 27, 2025Due to a potential open seal in the sterile barrier packagin |
| GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirationsClass IIMar 27, 2025Due to a potential open seal in the sterile barrier packagin |
| Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers arClass IIMar 27, 2025Due to a potential open seal in the sterile barrier packagin |
| Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewiresClass IIMar 27, 2025Due to a potential open seal in the sterile barrier packagin |
| Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16Class IIMay 8, 2023Sheath introducer assemblies could potentially, due to impro |
| Tearaway 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-01Class IIMay 8, 2023Sheath introducer assemblies could potentially, due to impro |