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.

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DateProductReasonClassFirm
Feb 25, 2021 Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an... Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... Class I Tenacore LLC
Feb 25, 2021 BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Mod... Their is a potential that the automated staining instrument with software version 3.5.3.1 may mo... Class II Biocare Medical, LLC
Feb 25, 2021 Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... Class I Tenacore LLC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, ... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 12, 2021 NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System ... Due to not having the full complement of biological assessments for all potential patients and as... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesio... Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. Class I Medtronic Vascular, Inc.
Feb 12, 2021 Precice Bone Transport - Product Usage: intended for limb lengthening, open... Due to complaints of adverse events potentially related to biological safety. The complaints inc... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening Syst... Due to not having the full complement of biological assessments for all potential patients and as... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail Sys... Due to not having the full complement of biological assessments for all potential patients and as... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 PRECICE STRYDE - Product Usage: intended for limb lengthening, open and clo... Due to complaints of adverse events potentially related to biological safety. The complaints inc... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 PRECICE PLATE - Product Usage: intended for limb lengthening, open and clos... Due to complaints of adverse events potentially related to biological safety. The complaints inc... Class II Nuvasive Specialized Orthopedics Inc
Feb 8, 2021 Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 conta... There is a potential that hand control units may cause the tabletop to slide in the opposite dire... Class II Mizuho OSI
Feb 5, 2021 System INFX-8000V The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc... Class II Canon Medical System, USA, INC.
Feb 5, 2021 System INFX-8000F The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc... Class II Canon Medical System, USA, INC.
Feb 5, 2021 System INFX-8000C The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc... Class II Canon Medical System, USA, INC.
Jan 29, 2021 Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma... Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emer... Class II Confirm Biosciences Inc
Jan 29, 2021 Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF G... Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emer... Class II Confirm Biosciences Inc
Jan 27, 2021 TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product ... Due to the release of nonconforming Intraocular Lenses (IOLs). Class II Johnson & Johnson Surgical Vision Inc
Jan 13, 2021 ENROUTE Transcarotid Stent System REF SR-XXYY-CS Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. Class II Silk Road Medical Inc
Jan 11, 2021 Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the foll... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 11, 2021 Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 11, 2021 Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II V... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 8, 2021 WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG ... Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. Class II Nihon Kohden America Inc
Jan 6, 2021 PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663... Due to unqualified "design verification" batteries being shipped to customers. Class II Respironics California, LLC
Dec 30, 2020 ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on th... The Quality Control (QC) card has a label error for the standard deviation (SD) values for one ou... Class II Beckman Coulter Inc.
Dec 29, 2020 REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile Missing Instruction For Use insert. Class II Allergan PLC
Dec 21, 2020 PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No.... Medical device non-conformance to electrical safety standard (IEC 60601-1). Class II Nihon Kohden America Inc
Dec 21, 2020 Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 ... Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the st... Class II Hardy Diagnostics
Dec 16, 2020 REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 16, 2020 REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 16, 2020 REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 15, 2020 Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 15, 2020 Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Devic... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 15, 2020 Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperf... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 15, 2020 Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization ... System table may tilt because the bolts that fasten the vertical column and the table top tilting... Class II Canon Medical System, USA, INC.
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization T... System table may tilt because the bolts that fasten the vertical column and the table top tilting... Class II Canon Medical System, USA, INC.
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization T... System table may tilt because the bolts that fasten the vertical column and the table top tilting... Class II Canon Medical System, USA, INC.
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 5, 2020 visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitativ... Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the pr... Class II VISBY MEDICAL INC
Dec 2, 2020 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Produ... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Produc... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage:... Due to the incorrect filter assembly. Class II ICU Medical, 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.