Browse Device Recalls
610 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 610 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 610 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 19, 2015 | Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene o... | Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientifi... | Class I | Boston Scientific Corporation |
| Oct 9, 2015 | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... | Class I | Boston Scientific Corporation |
| Oct 9, 2015 | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... | Class I | Boston Scientific Corporation |
| Sep 17, 2015 | Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). ... | Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communi... | Class II | Boston Scientific Corporation |
| Sep 11, 2015 | One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. | Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Bu... | Class II | Boston Scientific Corp |
| Aug 25, 2015 | Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F S... | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... | Class II | Boston Scientific Corporation |
| Aug 25, 2015 | Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Deliver... | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... | Class II | Boston Scientific Corporation |
| Jul 31, 2015 | AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jul 31, 2015 | AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized ... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jul 31, 2015 | AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog N... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jul 31, 2015 | AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, S... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jun 2, 2015 | CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, ... | Boston Scientific has received complaints indicating that, when using the blood pressure (BP) cha... | Class II | Boston Scientific Corporation |
| Apr 27, 2015 | Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon C... | One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrec... | Class II | Boston Scientific Corporation |
| Feb 25, 2015 | Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainag... | Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL ... | Class II | Boston Scientific Corporation |
| Feb 25, 2015 | Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Ca... | Complaints of device fragmentation after the catheter was implanted in the biliary system. The mo... | Class II | Boston Scientific Corporation |
| Feb 3, 2015 | IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material n... | Reports of formation of char adherent to the proximal part of the distal tip electrodes | Class I | Boston Scientific Corp |
| Nov 20, 2014 | IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64... | Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a ... | Class II | Boston Scientific Corp |
| Nov 19, 2014 | Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 19, 2014 | Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 19, 2014 | Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Sep 30, 2014 | StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457 | Product is not cleared for use with lasers other than the Auriga XL system | Class II | Boston Scientific Corporation |
| Sep 30, 2014 | StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453 | Product is not cleared for use with lasers other than the Auriga XL system | Class II | Boston Scientific Corporation |
| Sep 30, 2014 | StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455 | Product is not cleared for use with lasers other than the Auriga XL system | Class II | Boston Scientific Corporation |
| May 15, 2014 | IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Cur... | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... | Class II | Boston Scientific Corporation |
| May 15, 2014 | IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetr... | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... | Class II | Boston Scientific Corporation |
| May 15, 2014 | IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard ... | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... | Class II | Boston Scientific Corporation |
| May 15, 2014 | IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetri... | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... | Class II | Boston Scientific Corporation |
| May 15, 2014 | IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard ... | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... | Class II | Boston Scientific Corporation |
| May 15, 2014 | IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Cu... | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... | Class II | Boston Scientific Corporation |
| Apr 3, 2014 | iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul... | Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb... | Class II | Boston Scientific Corporation |
| Mar 3, 2014 | Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3... | The sterile pouch of the devices from this lot may not be completely sealed and sterility may be ... | Class II | Boston Scientific Corporation |
| Feb 4, 2014 | Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H... | Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... | Class II | Boston Scientific Corporation |
| Feb 4, 2014 | Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter,... | Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... | Class II | Boston Scientific Corporation |
| Jan 6, 2014 | Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Steriliz... | Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lum... | Class II | Boston Scientific Corporation |
| Dec 18, 2013 | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Inject... | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... | Class II | Boston Scientific Corporation |
| Dec 18, 2013 | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injec... | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... | Class II | Boston Scientific Corporation |
| Dec 18, 2013 | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects... | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Univ... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Unive... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univ... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Unive... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Inte... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univ... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 5, 2013 | Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M00625022... | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... | Class II | Boston Scientific Corporation |
| Nov 5, 2013 | Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M006250228... | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... | Class II | Boston Scientific Corporation |
| Nov 5, 2013 | Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M006250228... | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... | Class II | Boston Scientific Corporation |
| Jul 31, 2013 | Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio... | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... | Class II | Boston Scientific Corporation |
| Jul 31, 2013 | Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad... | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... | Class II | Boston Scientific Corporation |
| Jun 24, 2013 | Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat... | The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner... | Class II | Stryker Neurovascular |
| May 28, 2013 | NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog... | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... | 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.