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 18, 2024 | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R... | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system chec... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 18, 2024 | The Synchro Neuro Guidewires are a steerable guidewire family with a shapeabl... | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... | Class II | Stryker Neurovascular |
| Apr 18, 2024 | The Synchro SELECT Guidewires are a steerable guidewire family with a shapeab... | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... | Class II | Stryker Neurovascular |
| Apr 18, 2024 | The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip... | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... | Class II | Stryker Neurovascular |
| Apr 16, 2024 | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Rad... | A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. | Class II | Reflexion Medical, Inc. |
| Apr 15, 2024 | BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis MedStation ES, REF: 323, Medication Cabinet | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis" Anesthesia Station ES, REF: 327 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis(TM) Anesthesia Station 4000, REF: 338 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 10, 2024 | 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too b... | Due to incorrect milled titanium abutment being packaged and labeled. | Class II | Preat Corp |
| Apr 3, 2024 | The Distal Access Catheter is a single-lumen, braided shaft, variable stiffne... | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access... | Class II | Stryker Neurovascular |
| Apr 1, 2024 | LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Applicat... | Laser surgical instruments have no specific evidence of a validated reprocessing method, therefor... | Class II | Karl Storz Endoscopy |
| Mar 27, 2024 | Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5... | According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser prod... | Class II | Newport Corp |
| Mar 20, 2024 | 24K Premium Lense, Distributed by Updream Inc. | Contact lenses recalled due to potential bacterial contamination. | Class II | Ontact Inc |
| Mar 19, 2024 | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... | Nail system contains an out of specification driver-socket which could result in inability to pi... | Class II | TriMed Inc. |
| Mar 19, 2024 | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... | Nail system contains an out of specification driver-socket which could result in inability to pi... | Class II | TriMed Inc. |
| Mar 14, 2024 | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, | Their is a potential that breast implants lack the lubricious coating that allows them to slide ... | Class II | Allergan Sales, LLC |
| Mar 14, 2024 | Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Tes... | Due to a manufacturing variation of the irrigation sleeves which could result in a missing port h... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Mar 13, 2024 | Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, M... | Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry g... | Class II | Intuitive Surgical, Inc. |
| Mar 9, 2024 | Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Gal... | Due to a misaligned calibration of the wired controller that may result in unintended motion of t... | Class II | Noah Medical |
| Mar 8, 2024 | Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used f... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. ... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, Ster... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO.... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 6, 2024 | Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 | Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hou... | Class I | Outset Medical, Inc. |
| Mar 5, 2024 | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests | There are two windows on the test device, the control line window and the test results window. Th... | Class II | Quidel Corporation |
| Mar 5, 2024 | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests | There are two windows on the test device, the control line window and the test results window. Th... | Class II | Quidel Corporation |
| Mar 5, 2024 | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Co... | During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iO... | Class I | Tandem Diabetes Care, Inc. |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Mar 1, 2024 | 25-LHP-828, 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 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| 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 |
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.