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 |
|---|---|---|---|---|
| Apr 16, 2018 | Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 6... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD326... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 1000419... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: ... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: Th... | Two instrument holes located on the side of the plate, which act to align the saw guide are locat... | Class II | TriMed Inc. |
| Apr 16, 2018 | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-0... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 13, 2018 | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with F... | The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bez... | Class I | CareFusion 303, Inc. |
| Apr 13, 2018 | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca... | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-1... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 11, 2018 | FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm... | There may be product manufactured with the outer diameter of the balloon catheter exceeding the d... | Class II | Stryker Neurovascular |
| Apr 5, 2018 | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 1... | Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlu... | Class I | Abbott |
| Apr 4, 2018 | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage:... | Tip of the curing light was too hot causing a heat sensation in the patients. | Class II | Handpiece Headquarters |
| Apr 2, 2018 | AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000... | Following pressurization of the devices, damage to the device handle mechanism may occur, accompa... | Class II | AESDEX |
| Apr 2, 2018 | AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog N... | Following pressurization of the devices, damage to the device handle mechanism may occur, accompa... | Class II | AESDEX |
| Mar 30, 2018 | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System i... | The catheter alignment arrow printed onto the strain relief is not aligned with the detachment fe... | Class II | PENTAX of America Inc |
| Mar 30, 2018 | Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Comp... | There is a potential for the cutter head to detach from the cutter shaft. | Class II | Think Surgical, Inc. |
| Mar 29, 2018 | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iC... | The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufac... | Class II | Beckman Coulter Inc. |
| Mar 26, 2018 | BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Bro... | Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC... | Class II | Beckman Coulter Inc. |
| Mar 22, 2018 | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used... | The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and ... | Class II | Volcano Corporation |
| Mar 19, 2018 | HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. Fo... | Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated fol... | Class II | Hycor Biomedical Inc |
| Mar 16, 2018 | Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 3661... | The product label has missing information, such as the lot number and expiration date, as well as... | Class II | Nobel Biocare Usa Llc |
| Mar 15, 2018 | URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... | Class II | Biocare Medical, LLC |
| Mar 14, 2018 | ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platfor... | The cap on the vial might be labeled with the incorrect part number but the main vial label is co... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Mar 12, 2018 | Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TM... | This device was mislabeled and is not the correct component for this patient. | Class II | TMJ Solutions Inc |
| Mar 7, 2018 | da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Su... | Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (A... | Class II | Intuitive Surgical, Inc. |
| Mar 5, 2018 | ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medic... | The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 2, 2018 | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 70... | Beckman Coulter has determined that there is a potential for under-reporting casts. This can occu... | Class II | Beckman Coulter Inc. |
| Mar 2, 2018 | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-... | Beckman Coulter has determined that there is a potential for incorrect settings to be installed o... | Class II | Beckman Coulter Inc. |
| Feb 27, 2018 | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The... | It was discovered that the laser energy was not going where intended to put it, resulting in foca... | Class II | Iridex Corporation |
| Feb 26, 2018 | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 3... | There is a potential issue for all MindFrame Capture devices to partially detach or separate from... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 21, 2018 | True 3D Viewer, Model: EP-00003 | With certain software versions, import of enhanced ultrasound formatted data/ultrasound images in... | Class II | Echopixel, Inc. |
| Feb 21, 2018 | AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheum... | Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negati... | Class II | Hycor Biomedical Inc |
| Feb 15, 2018 | The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energ... | Lasers/Catheters did not calibrate during set-up prior to use. | Class II | Ra Medical Systems Inc |
| Feb 5, 2018 | 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer,... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouche... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotati... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Cla... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connect... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, 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.