Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 17, 2020 | Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY,... | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 17, 2020 | Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY... | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 17, 2020 | Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 17, 2020 | DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 5, 2020 | Philips V60 Ventilators with Power Management PCBA part number 1055906 | Solder connection failure on Power Management printed circuit board assembly of ventilators may c... | Class II | Respironics California, LLC |
| Mar 3, 2020 | Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Mar 3, 2020 | Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Mar 3, 2020 | Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Feb 28, 2020 | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The Merlin... | Internal testing of software identified software anomaly scenarios where if non-applicable shock ... | Class II | Abbott |
| Feb 26, 2020 | The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestin... | Ingestible video capsule system has capsule with incorrect capture mode which will not record dat... | Class II | Capso Vision, Inc. |
| Feb 25, 2020 | Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrate... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 25, 2020 | Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 25, 2020 | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Tra... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 25, 2020 | Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Tri... | An issue within production process used to package trial kits let to the inclusion of the incorr... | Class II | Kerr/Pentron, DBA Kerr Corporation and Pentron ... |
| Feb 25, 2020 | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Tran... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 17, 2020 | AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode... | hearing performance degradation due to body-fluid entering the device. | Class II | Advanced Bionics, LLC |
| Feb 17, 2020 | AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usa... | hearing performance degradation due to body-fluid entering the device. | Class II | Advanced Bionics, LLC |
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For ... | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 14, 2020 | The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; ... | Firm identified software issues which leads to the patient ID and patient information not being s... | Class II | ICU Medical, Inc. |
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 13, 2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product ... | Post-implantation separation of an actuator end cap component that may expose internal components... | Class II | NuVasive Inc |
| Feb 13, 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated power... | Due to programming errors in the Controller, an increase in the set motor parameters can be made ... | Class II | Sunrise Medical (US) LLC |
| Feb 10, 2020 | SPICE (JWH-018) CC443 | Corrections are being made to the device labeling regarding its intended use, to include a statem... | Class II | Carolina Liquid Chemistries Corp |
| Feb 4, 2020 | CareFusion Alaris Syringe Module, Model 8110 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris Pump Module, Model 8100 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris PCA Module, Model 8120 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 108854038... | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 3, 2020 | Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... | Class II | Dexcom Inc |
| Feb 3, 2020 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLAT... | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... | Class II | Dexcom Inc |
| Feb 3, 2020 | Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... | Class II | Dexcom Inc |
| Jan 31, 2020 | STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10... | Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | Class II | Applied Medical Resources Corp |
| Jan 31, 2020 | STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 ... | Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | Class II | Applied Medical Resources Corp |
| Jan 31, 2020 | STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 ... | Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | Class II | Applied Medical Resources Corp |
| Jan 31, 2020 | STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 ... | Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | Class II | Applied Medical Resources Corp |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 ... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 -... | Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human ser... | Class II | Beckman Coulter 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.