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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Apr 12, 2019 BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm... The firm has become aware of a potential problem with their venous and arterial magnetic catheter... Class II Bard Peripheral Vascular Inc
Dec 2, 2016 Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product ... Complaints of sheath separation, kinking, and/or tip damage during use. Class I BARD PERIPHERAL VASCULAR, INC
Dec 2, 2016 Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-... Complaints of sheath separation, kinking, and/or tip damage during use. Class I BARD PERIPHERAL VASCULAR, INC
Dec 2, 2016 Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage:... Complaints of sheath separation, kinking, and/or tip damage during use. Class I BARD PERIPHERAL VASCULAR, INC
Feb 9, 2016 Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J... Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and ... Class II Bard Peripheral Vascular Inc
Feb 9, 2016 Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicate... Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and ... Class II Bard Peripheral Vascular Inc
Feb 4, 2016 Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuid... Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles becau... Class II Bard Peripheral Vascular Inc
Jan 23, 2013 BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), Ultr... Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... Class II Bard Peripheral Vascular Inc
Jan 23, 2013 BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), Ultr... Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... Class II Bard Peripheral Vascular Inc

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.