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.

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DateProductReasonClassFirm
Apr 25, 2024 EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only Due to saline conductivity issues, their is a potential that dilation catheters may provide inacc... Class II Covidien, LLC
Apr 23, 2024 Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Cata... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 DAC 044 115cm, Catalog: 90760 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wi... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo Trak 21 Microcatheter, Catalog: 90338 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo ProVue, Catalog: 90184 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
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

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.