Browse Device Recalls

3,454 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,454 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 3,454 FDA device recalls — Class I.

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Date	Product	Reason	Class	Firm
Jul 24, 2019	Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Heigh...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styl...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioD...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), ...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intende...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Pro...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Proj...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander a...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Impl...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usag...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 24, 2019	RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML...	The action was initiated following notification by the U.S. FDA of their recently updated, global...	Class I	Allergan PLC
Jul 9, 2019	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv...	The action has been initiated to address reports of burst balloons which have resulted in signifi...	Class I	Edwards Lifesciences, LLC
Jul 9, 2019	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv...	The action has been initiated to address reports of burst balloons which have resulted in signifi...	Class I	Edwards Lifesciences, LLC
Jul 9, 2019	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv...	The action has been initiated to address reports of burst balloons which have resulted in signifi...	Class I	Edwards Lifesciences, LLC
Jul 9, 2019	Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv...	The action has been initiated to address reports of burst balloons which have resulted in signifi...	Class I	Edwards Lifesciences, LLC
Jun 24, 2019	Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Prod...	The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri...	Class I	Fenwal Inc
Jun 24, 2019	VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1...	The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri...	Class I	Fenwal Inc
Jun 20, 2019	ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum...	Class I	St Jude Medical Inc.
Jun 20, 2019	ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum...	Class I	St Jude Medical Inc.
Jun 20, 2019	ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: ...	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum...	Class I	St Jude Medical Inc.
Jun 20, 2019	ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: ...	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum...	Class I	St Jude Medical Inc.
Jun 20, 2019	ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: ...	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum...	Class I	St Jude Medical Inc.
Jun 20, 2019	ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum...	Class I	St Jude Medical Inc.
Jun 17, 2019	CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova...	If battery maintenance is not performed appropriately, the battery may provide less than the mini...	Class I	Datascope Corp.
Jun 17, 2019	CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova...	If battery maintenance is not performed appropriately, the battery may provide less than the mini...	Class I	Datascope Corp.
Jun 17, 2019	CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova...	If battery maintenance is not performed per instructions, the battery may provide less than the m...	Class I	Datascope Corp.
Jun 17, 2019	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card...	Battery short-run times and unanticipated stoppage may be due to user not performing battery main...	Class I	Datascope Corp.
Jun 17, 2019	CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova...	If battery maintenance is not performed per instructions, the battery may provide less than the m...	Class I	Datascope Corp.
Jun 17, 2019	Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card...	If battery maintenance is not performed appropriately, the battery may provide less than the mini...	Class I	Datascope Corp.
Jun 14, 2019	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with v...	Device vented gas below the stated pressure.	Class I	TELEFLEX-MORRISVILLE
Jun 7, 2019	Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.	Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes du...	Class I	Centurion Medical Products Corporation
Jun 5, 2019	Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used ...	Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with ...	Class I	Qiagen Sciences LLC
May 30, 2019	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 100...	Reports of pressure relief manifold venting gas below the standard pressure.	Class I	Galemed Corporation
May 30, 2019	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710...	Reports of pressure relief manifold venting gas below the standard pressure.	Class I	Galemed Corporation
May 30, 2019	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxyge...	Reports of pressure relief manifold venting gas below the standard pressure.	Class I	Galemed Corporation
May 29, 2019	Quantum Pump Console	Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut d...	Class I	Spectrum Medical Ltd.
May 24, 2019	Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Pro...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Trachea...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tub...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm,...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Ca...	Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia...	Class I	Cook Inc.
May 24, 2019	Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Cat...	Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia...	Class I	Cook Inc.
May 24, 2019	Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b)...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Cat...	Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia...	Class I	Cook Inc.
May 24, 2019	Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical

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.