Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 18, 2014 | HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M... | A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge ... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with ... | When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may ... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart M... | Wireless Link may be unable to transmit data when configured for a specific data flow. | Class II | Philips Medical Systems, Inc. |
| Feb 13, 2014 | GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.... | GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patien... | Class II | GE Healthcare, LLC |
| Feb 12, 2014 | CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... | Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2... | Class II | Biosense Webster, Inc. |
| Feb 7, 2014 | HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis... | In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional inform... | Class II | Leica Biosystems Imaging, Inc. |
| Feb 6, 2014 | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ... | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C... | Class II | Philips Medical Systems North America Inc. |
| Feb 5, 2014 | Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440... | Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number... | Class II | Alere San Diego, Inc. |
| Jan 30, 2014 | PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena ... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) P... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena In... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena ... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2001: Prevena Incision Management Customizable System Box Product Usage... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: ... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Man... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: Th... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 23, 2014 | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive,... | The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. | Class II | Atricure Inc |
| Jan 22, 2014 | SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless ... | CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connec... | Class II | CareFusion 303, Inc. |
| Jan 20, 2014 | Crimper Model 9100CR26 The Crimper is indicated for use in preparing the E... | Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper b... | Class II | Edwards Lifesciences, LLC |
| Jan 9, 2014 | Restoris Multicompartmental Knee (MCK) System is an implant system designed t... | The product may be mislabeled and could result in the incorrect implant being used. | Class II | Mako Surgical Corporation |
| Jan 7, 2014 | Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia ... | The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assem... | Class II | Synthes, Inc. |
| Dec 24, 2013 | 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCl... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron F... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating L... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Nee... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rot... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Lue... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rota... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connect... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave",... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoC... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item #... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Lue... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv C... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClav... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rota... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, R... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps,... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, P... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, 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.