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 |
|---|---|---|---|---|
| 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.