Browse Device Recalls
681 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 681 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 681 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 7, 2017 | ALTRUA 2 EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VISIONIST CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Nov 6, 2017 | Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and ... | Stent possibly unable to be fully released from the delivery system. | Class II | Boston Scientific Corporation |
| Nov 6, 2017 | Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and... | Stent possibly unable to be fully released from the delivery system. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therap... | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE EL ICD DR, Model D433, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | MOMENTUM X4 CRT-D, Model G138, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE EL ICD VR, Model D432, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE X4 CRT-D, Model G447, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Sep 22, 2017 | Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be ... | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... | Class II | Boston Scientific Corporation |
| Sep 22, 2017 | Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intende... | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrill... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is inten... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 15, 2017 | Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001... | Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. | Class II | Boston Scientific Corporation |
| Jun 1, 2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above... | Label on the affected devices incorrectly identifies the injection location as "above" the ball... | Class II | Boston Scientific Corporation |
| Jun 1, 2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below... | Label on the affected devices incorrectly identifies the injection location as "above" the ball... | Class II | Boston Scientific Corporation |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, ... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 15, 2017 | FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is int... | The device history record (DHR) was missing its test documentation for final HIPOT (high potentia... | Class II | Boston Scientific Corporation |
| Apr 5, 2017 | The JETSTREAM is a rotational atherectomy catheter system designed for use in... | Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lo... | Class II | Boston Scientific Corporation |
| Jan 31, 2017 | AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 ... | Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot swi... | Class II | Boston Scientific Corporation |
| Jan 12, 2017 | Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. | There is a potential for radio frequency (RF) interference to alter wireless communication from a... | Class II | Boston Scientific Corporation |
| Dec 15, 2016 | Boston Scientific Imager II Angiographic Catheter, a pathway for delivering c... | A field report indicated some units within this lot were missing the bottom pouch seal. The comp... | Class II | Boston Scientific Corporation |
| Dec 13, 2016 | Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p... | One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ... | Class II | Boston Scientific Corporation |
| Nov 30, 2016 | Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. | Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing le... | Class II | Boston Scientific Corporation |
| Oct 5, 2016 | Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Ca... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Car... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiolo... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiolo... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Card... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiol... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Card... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Ca... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Jun 15, 2016 | Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and E... | Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuratio... | Class II | Boston Scientific Corporation |
| Mar 28, 2016 | Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Co... | Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix ... | Class II | Boston Scientific Corporation |
| Mar 22, 2016 | Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. P... | Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving... | Class I | Boston Scientific Corporation |
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.