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 |
|---|---|---|---|---|
| May 26, 2021 | Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure M... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx On... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Steril... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 21, 2021 | Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic im... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 21, 2021 | Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Prod... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 21, 2021 | Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI Sys... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 21, 2021 | Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 19, 2021 | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imagin... | The firm is aware of a issue with ultrasound software that results in unintended video frames b... | Class II | Caption Health |
| May 7, 2021 | Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| May 7, 2021 | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| May 4, 2021 | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product ... | Software anomalies affecting the French, German and Italian versions of treatment delivery system... | Class II | Viewray, Inc. |
| Apr 28, 2021 | Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. ... | Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device... | Class II | Medtronic Vascular, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 23, 2021 | Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Pro... | Due to issue with product sterility. Sterilization service provider had falsified records. | Class II | Adler MicroMed, Inc. |
| Apr 21, 2021 | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 16, 2021 | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pum... | Class II | Hardy Diagnostics |
| Apr 14, 2021 | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, ... | specimens collected in transport media may result is false negative results when stored in certai... | 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.