Browse Device Recalls
1,708 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,708 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 1,708 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 6, 2018 | Single Chamber Temporary External Pacemaker, Model 53401 | A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 1, 2018 | Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1... | Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visu... | Class II | Medtronic Navigation, Inc. |
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 22, 2018 | Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 6... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tec... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tech... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, I... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, I... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 16, 2018 | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glu... | CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and di... | Class II | Medtronic Inc. |
| May 10, 2018 | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... | Class II | FHC, Inc. |
| May 10, 2018 | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product... | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... | Class II | FHC, Inc. |
| May 10, 2018 | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... | Class II | FHC, Inc. |
| May 10, 2018 | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Prod... | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... | Class II | FHC, Inc. |
| May 3, 2018 | Medtronic Clip Gun Magazines are packaged in individually sealed pouches and ... | The packaging sterile barrier does not comply with the applicable packaging standard for terminal... | Class II | Medtronic Neurosurgery |
| May 2, 2018 | Heartware Medtronic HVAD System for cardiac use. Including the following pa... | Possible transient electrical connection interruption between an HVAD System power source (Batter... | Class I | Heartware |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Ite... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( I... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BY... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo G... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA un... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BY... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BO... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKT... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) P... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA univer... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN 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.