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 |
|---|---|---|---|---|
| Dec 19, 2016 | DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Dec 12, 2016 | SwishTapered Implant | The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; L... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Dec 6, 2016 | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: T... | Accuray has become aware of a potential safety issue involving the possibility of electric shock ... | Class II | Accuray Incorporated |
| Dec 2, 2016 | Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/... | During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. | Class I | CareFusion 303, Inc. |
| Dec 2, 2016 | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmen... | Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces res... | Class II | Varian Medical Systems, Inc. |
| Nov 30, 2016 | 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating... | ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a... | Class II | ICU Medical, Inc. |
| Nov 28, 2016 | GoDirect Screw-Retaining Top Part Numbers: 4500-61 | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDi... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 23, 2016 | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335... | Design error when displaying additional information in the patient view window; error may result ... | Class II | Radiometer America Inc |
| Nov 22, 2016 | G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9... | During implantation, the proximal end of the device could separate if the angle between the devic... | Class II | Interventional Spine Inc |
| Nov 22, 2016 | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/... | Accuray has become aware of a potential safety issue involving unexpected treatment robot motion ... | Class II | Accuray Incorporated |
| Nov 21, 2016 | Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not fo... | Firm became aware that professional samples of Ceramax are not meeting stability standards set fo... | Class II | Oculus Innovative Sciences, Inc. |
| Nov 20, 2016 | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of... | Class II | Shimadzu Medical Systems |
| Nov 20, 2016 | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION saf... | Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possib... | Class II | Shimadzu Medical Systems |
| Nov 17, 2016 | SmartSite Add-On Bag Access Device, Model No. 10013365 | CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leaka... | Class II | CareFusion 303, Inc. |
| Nov 15, 2016 | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, St... | The vial cap was mislabeled with the incorrect part number of 855708 but the product description ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 7, 2016 | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. | The device defect associated with this recall may result in HbA1c values with a negative bias in ... | Class II | Tosoh Bioscience, Inc. |
| Nov 7, 2016 | Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6... | Firm received reports about "acquisition errors" and the deterioration of material covering the a... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 4, 2016 | MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool ... | The firm failed to notify current customers of IFU update/warning. During a recent FDA inspection... | Class II | Thayer Intellectual Property, Inc. |
| Nov 1, 2016 | Alaris System PC unit, model no. 8000 and 8015. The central programming, mon... | Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered bef... | Class II | CareFusion 303, Inc. |
| Oct 25, 2016 | Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system wit... | Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been ... | Class II | Toshiba American Medical Systems Inc |
| Oct 25, 2016 | MicroScan LabPro Data Management System. Intended to manage both microbial... | Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior whe... | Class II | Beckman Coulter Inc. |
| Oct 24, 2016 | Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access O... | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not... | Class II | Beckman Coulter Inc. |
| Oct 24, 2016 | Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The A... | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not... | Class II | Beckman Coulter Inc. |
| Oct 19, 2016 | AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing ... | Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased gene... | Class II | Beckman Coulter Inc. |
| Oct 14, 2016 | ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog... | ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak o... | Class II | Reshape Medical Inc |
| Oct 12, 2016 | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the p... | Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Val... | Class II | Alere San Diego, Inc. |
| Oct 10, 2016 | Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
| Oct 10, 2016 | Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
| Oct 10, 2016 | Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
| Oct 6, 2016 | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla... | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ... | Class II | AccessClosure, Inc., A Cardinal Health Company |
| Oct 5, 2016 | Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Ca... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Car... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cath... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiolo... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiolo... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Us... | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set sc... | Class II | Alphatec Spine, Inc. |
| Oct 5, 2016 | Alligator Retrieval Device The device is intended for use in the peripheral ... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | Pipeline Embolization Device (Pipeline Classic) The device is indicated for ... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Card... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software;... | Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can resu... | Class II | Intuitive Surgical, Inc. |
| Oct 5, 2016 | Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiol... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Card... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
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.