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.

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DateProductReasonClassFirm
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.
Dec 2, 2020 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron F... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of ant... Due to a customer report and internal investigation, it was confirmed that a portion of the affec... Class II Beckman Coulter Inc.
Nov 18, 2020 Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 18, 2020 Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspe... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 18, 2020 MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intend... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 12, 2020 CareLink Personal Software Therapy Management Software Tool for Diabetes Car... Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... Class II Medtronic Inc.
Nov 11, 2020 Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A A software problem has been identified which could result in the diagnostic imaging system not p... Class II Canon Medical System, USA, INC.
Nov 9, 2020 Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product... A software problem has been identified which could result in the CT Scanner not proceeding to th... Class II Canon Medical System, USA, INC.
Nov 9, 2020 icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... Due to a potential software issue, the display may show the incorrect continuous cardiac output (... Class II ICU Medical, Inc.
Nov 9, 2020 Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjust... There is a potential that the adjustable handle option on the X-Ray system may have been installe... Class II Shimadzu Medical Systems
Nov 3, 2020 Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed o... It has been determined that the software distributed with the retinal camera may delete patient i... Class II Kowa Optimed Inc
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC

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.