Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 9, 2019 | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components ... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.... | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Aug 9, 2019 | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic co... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with ... | Packages of abutments (universal base) may contain an incorrect screw. While the screw will tight... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components dire... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directl... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Jul 26, 2019 | da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with... | The firm become aware of a potentially defective capacitors on circuit boards installed on certai... | Class II | Intuitive Surgical, Inc. |
| Jul 26, 2019 | da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product... | The firm become aware of a potentially defective capacitors on circuit boards installed on certai... | Class II | Intuitive Surgical, Inc. |
| Jul 26, 2019 | da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product U... | The firm become aware of a potentially defective capacitors on circuit boards installed on certai... | Class II | Intuitive Surgical, Inc. |
| Jul 24, 2019 | RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usag... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Impl... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander a... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Proj... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Pro... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intende... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), ... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioD... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styl... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Heigh... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, St... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| 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 19, 2019 | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Onl... | The top label for dental implant may incorrectly indicate the implant length. Specifically, the l... | Class II | Nobel Biocare Usa Llc |
| Jul 12, 2019 | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing softw... | It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 ... | Class II | Dexcom Inc |
| 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 10, 2019 | Spectrum Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | ClubMax Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | Atom Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | Maxim Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Software Security; The action is being initiated because of software security vulnerabilities wi... | Class II | Radiometer America Inc |
| Jul 10, 2019 | Logolas Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics Inc |
| Jul 10, 2019 | Burstberry Laser Projection Series | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... | Class II | Gk Photonics 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 8, 2019 | BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The ... | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 8, 2019 | BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III i... | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 8, 2019 | BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSC... | The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encou... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 3, 2019 | CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Elect... | Possible mis-labeling of the device with incorrect serial number labels which may result in a pat... | Class II | Capso Vision, Inc. |
| Jul 1, 2019 | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 1163456... | Calibration; it has been determined that the capnographs may have been calibrated during manufact... | Class II | CareFusion 303, Inc. |
| Jul 1, 2019 | daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI... | The firm became aware of a manufacturing variation in which black and green reloads in select Sta... | Class II | Intuitive Surgical, Inc. |
| Jul 1, 2019 | daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UD... | The firm became aware of a manufacturing variation in which black and green reloads in select Sta... | Class II | Intuitive Surgical, Inc. |
| Jun 27, 2019 | Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 | The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... | Class II | Medtronic MiniMed |
| Jun 27, 2019 | Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K | The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... | Class II | Medtronic MiniMed |
| Jun 27, 2019 | Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K | The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... | Class II | Medtronic MiniMed |
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.