Browse Device Recalls
4,545 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,545 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 4,545 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 19, 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... | Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... | Class III | NuVasive Inc |
| Jul 5, 2022 | ZAP-X Radiosurgery System | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to ... | Class II | Zap Surgical Systems |
| Jul 1, 2022 | Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jul 1, 2022 | Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jun 30, 2022 | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 30, 2022 | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 29, 2022 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to intro... | Outside packaging for a device indicated for introducing cardiovascular catheters into the heart,... | Class II | Biosense Webster, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock B... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock ... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| Jun 24, 2022 | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool | There is the potential that during implant deployment, the device may not properly deliver a imp... | Class II | Neotract Inc |
| Jun 24, 2022 | The Cholestech LDX¿ System combines enzymatic methodology and solidphase tec... | Cholesterol test cassettes package insert is to be updated with new bilirubin interference inform... | Class II | Alere San Diego, Inc. |
| Jun 22, 2022 | The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) de... | Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar e... | Class II | Intuitive Surgical, Inc. |
| Jun 20, 2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, H... | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Tra... | Class II | NuVasive Inc |
| Jun 17, 2022 | Merlin.net model MN5000 Software | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 17, 2022 | Merlin PCS 3650 programmer Model 3330 software | There is a potential for programmer software (Merlin PCS) and remote monitoring software applicat... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 17, 2022 | Merlin 2 PCS MER37000 programmer Model MER3400 software | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 9, 2022 | CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... | Class II | Zeltiq Aesthetics, Inc |
| Jun 9, 2022 | CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... | Class II | Zeltiq Aesthetics, Inc |
| Jun 9, 2022 | CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... | Class II | Zeltiq Aesthetics, Inc |
| Jun 9, 2022 | CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... | Class II | Zeltiq Aesthetics, Inc |
| Jun 9, 2022 | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... | Class II | Zeltiq Aesthetics, Inc |
| Jun 3, 2022 | Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE... | Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. | Class II | Stryker Neurovascular |
| May 30, 2022 | OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for chil... | Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring i... | Class II | Ossur Americas |
| May 24, 2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... | Class II | Tandem Diabetes Care Inc |
| May 24, 2022 | BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with ... | The automated dispensing cabinet software update included a .dll file that is not compatible with... | Class II | CareFusion 303, Inc. |
| May 24, 2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... | Class II | Tandem Diabetes Care Inc |
| May 23, 2022 | MiniMed 630G Insulin Pump (U.S. and Canada Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 620G Insulin Pump (O.U.S. version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 780G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 640G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 720G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 740G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 20, 2022 | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2... | Label provided for substrate vail contained incorrect expiration date. | Class III | Agilent Technologies, Inc. |
| May 16, 2022 | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 | Due to a potential failed sterilization process. | Class II | Volcano Corp |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , R... | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Volcano Corp |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx ... | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Volcano Corp |
| May 3, 2022 | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSe... | cybersecurity vulnerability | Class II | Illumina, Inc. |
| May 3, 2022 | illumina Model NextSeq 550 Dx REF 20005715 | cybersecurity vulnerability | Class II | Illumina, Inc. |
| May 3, 2022 | STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF... | The endoscope may experience a loss of image when activating monopolar electrocautery, due a manu... | Class II | Karl Storz Endoscopy |
| May 3, 2022 | System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model ... | CT operation may be restricted by an interlock which is a result of an system error and the CT sy... | Class II | Canon Medical System, USA, INC. |
| Apr 29, 2022 | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to s... | Due to products being shipped/distributed to customers after the products expiration date had past. | Class II | Nihon Kohden America Inc |
| Apr 27, 2022 | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil Syst... | Due to incorrect size and configuration labeling of the detachable coil system. | Class II | Micro Therapeutics, Inc. |
| Apr 7, 2022 | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reor... | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Mod... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 6, 2022 | Accula SARS-CoV-2 Test, REF: COV4100 | SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay ... | Class I | MESA BIOTECH, INC |
| Apr 6, 2022 | TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, | Potential breach in the sterility barrier for tray ring covers. | Class II | Johnson & Johnson Surgical Vision Inc |
| Apr 1, 2022 | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VA... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 ... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
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.