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 |
|---|---|---|---|---|
| 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. |
| Feb 2, 2018 | PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 leve... | To correct the kit's instructions for use as the storage time for gastric and gastroesophageal ju... | Class II | Dako North America Inc. |
| Jan 29, 2018 | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytomet... | The device may process the same sample with two different sample IDs and sample information while... | Class II | Beckman Coulter Inc. |
| Jan 26, 2018 | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, h... | The device power supply was not manufactured according to specification which can result in the l... | Class II | Inova Diagnostics Incorporated |
| Jan 26, 2018 | QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, h... | The device power supply was not manufactured according to specification which can result in the l... | Class II | Inova Diagnostics Incorporated |
| Jan 26, 2018 | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imag... | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 25, 2018 | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based ... | The recalled products were shipped without the required temperature control packaging, therefore ... | Class II | Stryker Corporation |
| Jan 23, 2018 | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0m... | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 20, 2018 | Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: Th... | The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and... | Class II | Hologic, Inc |
| Jan 19, 2018 | AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125... | Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing pr... | Class II | Beckman Coulter Inc. |
| Jan 19, 2018 | SwishTapered Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 19, 2018 | SwishPlus Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 18, 2018 | AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standar... | A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to caus... | Class II | Beckman Coulter Inc. |
| Jan 12, 2018 | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 12, 2018 | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiograp... | When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or ch... | Class II | Shimadzu Medical Systems |
| Jan 12, 2018 | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 11, 2018 | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO... | Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color ba... | Class II | TriMed 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.