Browse Device Recalls
94 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 94 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 94 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product ... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Jun 11, 2018 | Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm | SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. | Class II | Edwards Lifesciences, LLC |
| Mar 30, 2018 | Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in ... | Possible leak at distal open end of the strain relief, which causes medical staff to continue add... | Class II | Edwards Lifesciences, LLC |
| Oct 2, 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor,... | Pre-procedural issues related to software defects | Class II | Edwards Lifesciences, LLC |
| Jul 21, 2017 | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9... | A component in the Certitude Loader may have a molding overflow defect that could detach during ... | Class I | Edwards Lifesciences, LLC |
| Jul 6, 2017 | Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Us... | The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. | Class II | Edwards Lifesciences, LLC |
| Nov 13, 2015 | Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2... | Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement o... | Class II | Edwards Lifesciences, LLC |
| Nov 4, 2015 | Thin-Flex Venous Cannula, Model Number:TF292902A | Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) ... | Class II | Edwards Lifesciences, LLC |
| Aug 26, 2015 | ThruPort Knot Pusher. This device is sold individually (Model KP1) and as par... | The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fra... | Class II | Edwards Lifesciences, LLC |
| May 18, 2015 | ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Plat... | Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart ... | Class II | Edwards Lifesciences, LLC |
| May 5, 2015 | Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number I... | Potential device damage on the strain relief near the hub area, which may result in blood leakage. | Class II | Edwards Lifesciences, LLC |
| May 5, 2015 | Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. F... | The product failed to meet the internal established statistical test requirement for heparin acti... | Class II | Edwards Lifesciences, LLC |
| Mar 23, 2015 | Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,St... | Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 ... | Class II | Edwards Lifesciences, LLC |
| Oct 8, 2014 | Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in ... | Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for ... | Class II | Edwards Lifesciences, LLC |
| Apr 9, 2014 | Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo C... | Potential for separation of dilator tips. | Class II | Edwards Lifesciences, LLC |
| Apr 9, 2014 | Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial can... | Potential for separation of dilator tips. | Class II | Edwards Lifesciences, LLC |
| 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 |
| Nov 20, 2013 | Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straig... | Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scis... | Class III | Edwards Lifesciences, LLC |
| Sep 16, 2013 | Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D,... | Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformat... | Class I | Edwards Lifesciences, LLC |
| Aug 26, 2013 | Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating... | Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi... | Class II | Edwards Lifesciences, LLC |
| Aug 26, 2013 | Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, ... | Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi... | Class II | Edwards Lifesciences, LLC |
| Jul 31, 2013 | "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors ... | The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ... | Class II | Edwards Lifesciences, LLC |
| Jul 30, 2013 | Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1... | Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concer... | Class II | Edwards Lifesciences, LLC |
| Jul 16, 2013 | Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: ... | Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were buil... | Class II | Edwards Lifesciences, LLC |
| Jun 19, 2013 | Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands ar... | Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particul... | Class II | Edwards Lifesciences, LLC |
| May 14, 2013 | QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (2... | Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during... | Class II | Edwards Lifesciences, LLC |
| Mar 26, 2013 | Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to ... | Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing o... | Class II | Edwards Lifesciences, LLC |
| Mar 26, 2013 | Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to ... | Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing o... | Class II | Edwards Lifesciences, LLC |
| Mar 14, 2013 | Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: T... | Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly seale... | Class II | Edwards Lifesciences, LLC |
| Jan 30, 2013 | Pressure Monitoring sets with VAMP Plus closed blood sampling system model # ... | The device is being recalled because the firm has received multiple complaints related to incorr... | Class II | Edwards Lifesciences, LLC |
| Jan 25, 2013 | Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with... | Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to conf... | Class II | Edwards Lifesciences, LLC |
| Jun 6, 2012 | Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC... | Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. F... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. F... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
| May 11, 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. ... | The device is being recalled because the firm received multiple complaints related to passage of ... | Class II | Edwards Lifesciences, LLC |
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.