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 |
|---|---|---|---|---|
| Mar 1, 2024 | N-LHP-928, HeNe Laser System, 35 mW | These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each l... | Class II | PACIFIC LASERTECH, LLC |
| Mar 1, 2024 | 25-LHP-928, HeNe Laser System, 25 mW | These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each l... | Class II | PACIFIC LASERTECH, LLC |
| Mar 1, 2024 | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | There is a potential that the Cholestech LDX battery (an external battery pack available as an op... | Class II | Alere San Diego, Inc. |
| Feb 28, 2024 | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alph... | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only | Inadequate reprocessing validation evidence | Class II | Karl Storz Endoscopy |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only,... | Inadequate reprocessing validation evidence | Class II | Karl Storz Endoscopy |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE | Inadequate reprocessing validation evidence | Class II | Karl Storz Endoscopy |
| Feb 23, 2024 | BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and di... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store ... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and ... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense m... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 19, 2024 | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 19, 2024 | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 16, 2024 | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOT... | Due to a manufacturing issue, device under process validation phase were inadvertently mixed into... | Class II | Biosense Webster, Inc. |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial ... | Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperativ... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower ... | Class II | Bio-Rad Laboratories |
| Feb 12, 2024 | Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument S... | There is a galling effect (cold-weld) caused by friction between the array fixation pins and the ... | Class II | Think Surgical, Inc. |
| Feb 9, 2024 | Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 | Due to a manufacturing issue, the screw seat location on the abutment product may be too high, ca... | Class II | Preat Corp |
| Feb 5, 2024 | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO | Their is a potential that electromagnetic interference may cause leadless pacemaker may result in... | Class II | Abbott Medical |
| Feb 1, 2024 | BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStatio... | Automated dispensing cabinets, running affected software, and Windows 10 operating system may exp... | Class II | CareFusion 303, Inc. |
| Jan 30, 2024 | Epix Universal Clip Applier, REF: CA500, STERILEEO included within the follow... | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Class II | Applied Medical Resources Corp |
| Jan 30, 2024 | Epix Universal Clip Applier, REF: CA500, STERILEEO | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Class II | Applied Medical Resources Corp |
| Jan 29, 2024 | MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val... | Class II | Canon Medical System, USA, INC. |
| Jan 29, 2024 | Vantage Titan, Model: MRT-1504 | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val... | Class II | Canon Medical System, USA, INC. |
| Jan 29, 2024 | MRI system: Vantage Elan, Model: MRT-2020 | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val... | Class II | Canon Medical System, USA, INC. |
| Jan 26, 2024 | IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-8... | Due to reports of intraoperative graft bolt implantation breakages. | Class II | Alphatec Spine, Inc. |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection ... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 11, 2024 | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... | European version of microcatheter were distributed within US which contain a different "Indicatio... | Class II | Micro Therapeutics, Inc. |
| Jan 11, 2024 | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... | European version of microcatheter were distributed within US which contain a different "Indicatio... | Class II | Micro Therapeutics, Inc. |
| Jan 3, 2024 | The Prestige Coil System is a product family of embolic coils with associated... | Discoloration was identified along the delivery pusher which was attributed to corrosion of the h... | Class II | BALT USA, LLC |
| Jan 3, 2024 | Neurovascular embolization device. The Optima Coil System is a series special... | Discoloration was identified along the delivery pusher which was attributed to corrosion of the h... | Class II | BALT USA, LLC |
| Jan 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Jan 3, 2024 | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a... | One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration... | Class II | Quidel Corporation |
| Dec 27, 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible... | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | Class II | TruAbutment Inc. |
| Dec 21, 2023 | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 | Due to, during the manufacturing process, the prescribed manufacturing and quality processes were... | Class II | MICROVENTION INC. |
| Dec 15, 2023 | PANTHER FUSION System REF 9121010000 The Panther System is an integrated... | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. | Class II | Hologic, Inc. |
| Dec 12, 2023 | TECNIS Toric II OptiBlue IOL Models ZCW | Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks ... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Nov 28, 2023 | External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... | Class II | Natus Medical Incorporated |
| Nov 28, 2023 | EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... | Class II | Natus Medical Incorporated |
| Nov 28, 2023 | Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S,... | Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop ou... | Class II | TriMed Inc. |
| Nov 15, 2023 | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3... | Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.... | Class II | Medtronic MiniMed, Inc. |
| Nov 15, 2023 | The device is an X-ray system that is capable of radiographic and fluoroscopi... | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... | Class II | Canon Medical System, USA, 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.