Browse Device Recalls
603 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 603 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 603 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 22, 2020 | Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MC... | Incorrectly installed base. | Class II | Boston Scientific Corporation |
| Sep 22, 2020 | Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSI... | There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in ... | Class II | Boston Scientific Corporation |
| Sep 16, 2020 | Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; ... | RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. | Class II | Boston Scientific Corporation |
| Aug 24, 2020 | Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expirat... | Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping le... | Class II | Boston Scientific Corporation |
| Aug 7, 2020 | WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M... | Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Bil... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire ca... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visu... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescript... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescripti... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Pr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescript... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Pre... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit V... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Pr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Mar 30, 2020 | MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be... | To reinforce existing instructions within the Directions for Use (DFU) and provide further guidan... | Class II | Boston Scientific Corporation |
| Feb 12, 2020 | Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR,... | Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... | Class II | Boston Scientific Corporation |
| Feb 12, 2020 | Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:Th... | Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... | Class II | Boston Scientific Corporation |
| Feb 11, 2020 | Imager II 5F Angiographic Catheters, 5 units per package. | Potential for tip detachment of Imager II 5F Angiographic Catheters | Class I | Boston Scientific Corporation |
| Dec 17, 2019 | AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod... | A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib... | Class II | Boston Scientific Corporation |
| Nov 18, 2019 | Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product... | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the... | Class II | Boston Scientific Corporation |
| Nov 18, 2019 | Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product... | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the... | Class II | Boston Scientific Corporation |
| Nov 8, 2019 | AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H ... | Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's ... | Class II | Boston Scientific Corporation |
| Oct 24, 2019 | Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. P... | Certain dilation and extension catheters are being recalled because these catheters may have miss... | Class II | Boston Scientific Corporation |
| Oct 24, 2019 | Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, ... | Certain dilation and extension catheters are being recalled because these catheters may have miss... | Class II | Boston Scientific Corporation |
| Oct 24, 2019 | Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Pack... | Certain dilation and extension catheters are being recalled because these catheters may have miss... | Class II | Boston Scientific Corporation |
| Oct 24, 2019 | NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide... | Certain dilation and extension catheters are being recalled because these catheters may have miss... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Sep 18, 2019 | iLab Polaris Multi-Modality Guidance System; iLab Ultraso... | Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batc... | Class II | Boston Scientific Corporation |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | 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.