Browse Device Recalls

1,694 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,694 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 1,694 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jul 13, 2017	Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi...	Stylette removal difficulties on the Euphora and Solarice products.	Class II	Medtronic Vascular Galway DBA Medtronic Ireland
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERIL...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STE...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STER...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx O...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 6...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	Spine Referencing Instrumentation, Spinous Process Clamp, Short When used wi...	Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 04404...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERIL...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used wit...	Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This k...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, ST...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When u...	Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx ...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STER...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on ...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a)...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When ...	Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on th...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, N...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Shor...	Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, R...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit incl...	The instruments are not able to pass instrument verification which is performed prior to the use ...	Class II	Medtronic Navigation, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 6272550...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 29, 2017	SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERI...	Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ...	Class II	Sorin Group USA, Inc.
Jun 22, 2017	DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du...	Identification of small pinholes in a single packaging configuration of sterile pouches. A total...	Class II	Medtronic Perfusion Systems
Jun 22, 2017	DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in...	Identification of small pinholes in a single packaging configuration of sterile pouches. A total...	Class II	Medtronic Perfusion Systems
Jun 22, 2017	DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m...	Identification of small pinholes in a single packaging configuration of sterile pouches. A total...	Class II	Medtronic Perfusion Systems
Jun 22, 2017	DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern...	Identification of small pinholes in a single packaging configuration of sterile pouches. A total...	Class II	Medtronic Perfusion Systems
Jun 22, 2017	DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o...	Identification of small pinholes in a single packaging configuration of sterile pouches. A total...	Class II	Medtronic Perfusion Systems
Jun 7, 2017	Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9...	Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (...	Class II	Medtronic Navigation, Inc.
May 17, 2017	KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.	The directional arrow at the proximal end of the instrument may not correctly align with the cut...	Class II	Medtronic Sofamor Danek USA Inc
May 10, 2017	Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.	Software issue related to the StealthStation S7 system and the Synergy Spine application Version ...	Class II	Medtronic Navigation, Inc.
May 8, 2017	MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,...	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
May 8, 2017	MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
May 8, 2017	MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,...	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
May 8, 2017	MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,...	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
May 3, 2017	Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 ...	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933;...	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	USPACK-SUTURE KIT; Item Number: US1672	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211,...	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 17...	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	CUSTOM SUTURE PACK; Item Number: US1540 and US1614	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	SCHRITTMACHER ANGIO X3; Item Number: 4045255423347	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic

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.