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Browse Device Recalls

20 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 20 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 20 FDA device recalls.

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DateProductReasonClassFirm
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 Galt Medical Corporation
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 Galt Medical Corporation
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 Galt Medical Corporation
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 Galt Medical Corporation
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 Galt Medical Corporation
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 Galt Medical Corporation
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 Galt Medical Corporation
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 conditions, have a luer c... Class II Galt Medical Corporation
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 conditions, have a luer c... Class II Galt Medical Corporation
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 wall) resulting in ... Class II Galt Medical Corporation
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 (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 TVS LPA, Catalog #: DIL-059-00 The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
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 (Pyrogens) that were intr... Class II Galt Medical Corporation
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 (Pyrogens) that were intr... Class II Galt Medical Corporation
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 (Pyrogens) that were intr... Class II Galt Medical Corporation
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 (Pyrogens) that were intr... Class II Galt Medical Corporation
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 (Pyrogens) that were intr... Class II Galt Medical Corporation
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 (Pyrogens) that were intr... Class II Galt Medical Corporation
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 through the valve which... Class II Galt Medical Corporation
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 through the valve which... Class II Galt Medical Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.