Galt Medical Corporation
Complete recall history across all FDA and CPSC categories — 20 total recalls
Galt Medical Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (20)
FDA medical device enforcement actions by Galt Medical Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 27, 2025 | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intende... | Due to a potential open seal in the sterile barrier packaging . | Class II |
| Mar 27, 2025 | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34... | Due to a potential open seal in the sterile barrier packaging. | Class II |
| Mar 27, 2025 | Introducer Needle REF NDL-107-04 These needles are used for the percutane... | Due to a potential open seal in the sterile barrier packaging. | Class II |
| Mar 27, 2025 | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101... | Due to a potential open seal in the sterile barrier packaging. | Class II |
| Mar 27, 2025 | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 61280... | Due to a potential open seal in the sterile barrier packaging . | Class II |
| Mar 27, 2025 | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-0... | Due to a potential open seal in the sterile barrier packaging . | Class II |
| Mar 27, 2025 | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutan... | Due to a potential open seal in the sterile barrier packaging. | Class II |
| May 8, 2023 | Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12,... | Sheath introducer assemblies could potentially, due to improper storage condi... | Class II |
| May 8, 2023 | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | Sheath introducer assemblies could potentially, due to improper storage condi... | Class II |
| Nov 16, 2020 | Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Ce... | Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker... | Class II |
| May 2, 2018 | 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilat... | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| May 2, 2018 | TVS LPA, Catalog #: DIL-059-00 | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| May 2, 2018 | 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog... | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| May 2, 2018 | 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) ... | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| May 2, 2018 | Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; ... | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| May 2, 2018 | Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-... | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| May 2, 2018 | Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| May 2, 2018 | 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05... | The products listed might contain unsafe levels of bacterial endotoxins (Pyro... | Class II |
| Jul 25, 2014 | GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-S... | The adhesive used in the product could dislodge when objects are inserted thr... | Class II |
| Jul 25, 2014 | GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO ... | The adhesive used in the product could dislodge when objects are inserted thr... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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