Browse Device Recalls

36 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 36 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 36 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 20, 2019 ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Apr 16, 2018 Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846;... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; ... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650... The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... Class II St Jude Medical Inc.
Apr 16, 2018 Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 6... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; ... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD326... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, ... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 1000419... The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Apr 16, 2018 St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: ... The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... Class II St Jude Medical Inc.
Apr 16, 2018 Merlin PCS programmer (Model # 3650), Software (Model # 3330) The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... Class II St Jude Medical Inc.
Aug 28, 2017 Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... The device may exhibit premature battery depletion. Class I St Jude Medical Inc.
Aug 28, 2017 PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) dev... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker ... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... The device may exhibit premature battery depletion. Class I St Jude Medical Inc.
Aug 28, 2017 PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (L... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, P... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Acce... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber ... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merli... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models E... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devic... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical 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.
Mar 31, 2016 Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411... St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the... Class II St Jude 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.