Browse Device Recalls

39,885 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,885 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 39,885 FDA device recalls.

DateProductReasonClassFirm
Jun 15, 2026 GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1... Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. Class II Terumo Medical Corporation
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x ... Catheters, indicated for short/long-term peripheral access to central venous system for the admin... Class II Argon Medical Devices, Inc
Jun 15, 2026 L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 Catheters, indicated for short/long-term peripheral access to central venous system for the admin... Class II Argon Medical Devices, Inc
Jun 12, 2026 ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative m... The Test cup lot F level 1 low-quality control results values for the device were lower than expe... Class II Tosoh Bioscience Inc
Jun 11, 2026 Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model... Due to a defective circuit board that overheats Class II Oxos Medical Inc
Jun 11, 2026 Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity P... The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64... The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 IQon Spectral CT IQon Spectral CT Upgrades The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vas... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU D... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART M... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablat... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline K... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutan... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that i... Class II Boston Scientific Corporation
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculatur... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 2... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containi... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP;... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; co... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Produc... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containi... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; ... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, cont... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Produc... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Intro... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550,... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, cont... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella In... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 10, 2026 Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0... Software issue that can cause an increase in spontaneous software closures. Class II Foundation Medicine, Inc.
Jun 10, 2026 Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... Class II Medline Industries, LP
Jun 10, 2026 Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... Class II Medline Industries, LP
Jun 10, 2026 Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infus... In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... Class II ICU Medical, Inc.
Jun 10, 2026 Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor 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.