Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 19, 2019 | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910... | Complaints have been received regarding difficulty in removing the driver from the screw. High d... | Class II | Stryker Corporation |
| Jul 19, 2019 | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-47... | Complaints have been received regarding difficulty in removing the driver from the screw. High d... | Class II | Stryker Corporation |
| Jul 12, 2019 | ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-00... | Firm identified several software issues through internal testing of its Cogent Hemodynamic Monito... | Class II | ICU Medical, Inc. |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 1, 2019 | LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used f... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jun 27, 2019 | Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PE... | It has been determined that some Pedicle system screw identified as 45mm long have an actual len... | Class II | Medicrea International |
| Jun 12, 2019 | ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO ... | There is a potential for the device to fail to deliver energy to the patient. | Class II | ZOLL Medical Corporation |
| Jun 3, 2019 | BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 3... | The products have been confirmed to have reduced or no additive within the tube reservoir. The t... | Class II | Becton Dickinson & Company |
| Jun 1, 2019 | Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Hepari... | False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutaine... | Class II | Centurion Medical Products Corporation |
| May 29, 2019 | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Produ... | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has ... | Class II | AtriCure, Inc. |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usag... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage:... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 17, 2019 | EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 10, 2019 | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode... | Possible corrosion of the battery contact(s). | Class III | Cardiocommand Inc. |
| Apr 26, 2019 | Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-10... | may contain a damaged gray safety lock knob, which could potentially result in difficulty or an i... | Class II | Cook Inc. |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 3, 2019 | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article ... | Dental adaptor does not conform to specifications. The dental coupling of the adapter can become ... | Class II | Thommen Medical AG |
| Apr 1, 2019 | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Nu... | Pin hole package failures compromising sterility of product | Class II | Dornier Medtech America, Inc. |
| Mar 30, 2019 | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only,... | Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... | Class II | Thoratec Corp. |
| Mar 30, 2019 | Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 1055... | Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... | Class II | Thoratec Corp. |
| Mar 28, 2019 | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, ... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 28, 2019 | Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 12, 2019 | PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intende... | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... | Class II | Ethicon, Inc. |
| Mar 1, 2019 | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an opti... | Small black plastic particle was observed in the left ventricle during implant procedure. | Class II | Thoratec Corp. |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgi... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical an... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 21, 2019 | icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Ad... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). ... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Gradu... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV admin... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV admini... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administr... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) ... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 18, 2019 | LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCUL... | Certain product code/lot number combinations may experience introducer sheath compatibility issu... | Class II | Bard Peripheral Vascular Inc |
| Jan 22, 2019 | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 14, 2019 | TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... | Two issues: Event 1: Normal operation of the device is to power up the device in the morning, ... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 14, 2019 | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices ar... | Devices may generate excessive heat during use. | Class II | Arthrex, Inc. |
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.