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 |
|---|---|---|---|---|
| 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 |
| Oct 9, 2019 | Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI E... | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... | Class II | Medivators, Inc. |
| 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 |
| Jul 19, 2019 | AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: ... | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. | Class II | Boston Scientific Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is i... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Elec... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Elec... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is i... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is ind... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 8, 2019 | AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: ... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Au... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: ... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Aur... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL ... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The A... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The A... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Dec 26, 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, M... | The sterile barrier may contain packaging seal defects. | Class II | Boston Scientific Corporation |
| Dec 26, 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Ma... | The sterile barrier may contain packaging seal defects. | Class II | Boston Scientific Corporation |
| Dec 19, 2018 | Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of b... | A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. | Class II | Boston Scientific Corporation |
| Nov 28, 2018 | IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri... | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change... | Class III | Boston Scientific Corporation |
| Nov 28, 2018 | Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrig... | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change... | Class III | Boston Scientific Corporation |
| Nov 28, 2018 | IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri... | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change... | Class III | Boston Scientific Corporation |
| Nov 1, 2018 | The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardiov... | Experienced accelerated battery depletion and a shortened replacement interval due to latent inte... | 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.