The Recall Desk

Hazard

Unauthorized Access recalls

84 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
84
Critical
1
Severe
8
Most recent
2026-07-09

Of the 84 unauthorized access recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (10%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unauthorized access recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

51–75 of 84

  • HighFDA (Devices)·Z-2325-2018·2018-07-04

    St Jude Medical Recalls Quadra Assura MP Implantable Cardiac Devices for Security Update

    St Jude Medical is recalling 68,117 Quadra Assura MP implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2018·2018-07-04

    St Jude Medical Recalls Promote Quadra ICDs for Security Firmware Update

    St Jude Medical is recalling Promote Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2018·2018-07-04

    St Jude Medical Recalls Unify Assura ICDs for Security Firmware Update

    St Jude Medical is recalling Unify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2018·2018-07-04

    St Jude Medical Recalls Implantable Cardiac Devices for Security Firmware Update

    St Jude Medical is recalling implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 600107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2018·2018-07-04

    St Jude Medical Recalls Fortify ICDs and CRT-Ds for Security Firmware Update

    St Jude Medical is recalling Fortify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access. Older devices may require permanent disabling of RF communication.

    Product
    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2018·2018-07-04

    St Jude Medical Recalls Quadra Assura ICDs for Security Firmware Update

    St Jude Medical is recalling 72,673 Quadra Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2018·2018-07-04

    St Jude Medical Recalls High Voltage Implantable Cardiac Devices for Security Firmware

    St Jude Medical is releasing new firmware for high voltage implantable cardiac devices to strengthen security against unauthorized access.

    Product
    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2018·2018-07-04

    St Jude Medical Recalls Unify ICDs for Security Firmware Update

    St Jude Medical is recalling Unify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.

    Product
    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 1000370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2018·2018-07-04

    St Jude Medical Recalls Fortify Assura ICDs for Security Firmware Update

    St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/10004294
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2018·2018-07-04

    St Jude Medical Recalls Ellipse ICDs for Security Firmware Update

    St Jude Medical is recalling Ellipse ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.

    Product
    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0035-2018·2017-10-25

    St Jude Medical Recalls 101 Implantable Pacemakers for Firmware Update

    St Jude Medical is recalling 101 implantable pacemaker pulse generators to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0036-2018·2017-10-25

    St Jude Medical Recalls ZENEX Pacemakers for Firmware Update

    St Jude Medical is recalling 4,828 ZENEX pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimu
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0034-2018·2017-10-25

    St Jude Medical Recalls Nuance Pacemakers for Firmware Update

    St Jude Medical is recalling 2,741 Nuance pacemakers to install new firmware that mitigates the risk of unauthorized access to the devices' radio frequency communications.

    Product
    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0037-2018·2017-10-25

    St Jude Medical Recalls PM 1260 Assurity+ Pacemakers for Firmware Update

    St Jude Medical is recalling 6,051 PM 1260 Assurity+ pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are us
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0031-2018·2017-10-25

    St Jude Medical Recalls Assurity MRI Pacemakers for Firmware Update

    St Jude Medical is recalling 164,366 Assurity MRI pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those sympto
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0029-2018·2017-10-25

    St Jude Medical Recalls Pacemakers for Unauthorized Access Risk

    St Jude Medical is recalling specific Anthem and Allure/Relieve pacemakers to mitigate the risk of unauthorized access via radio frequency communications.

    Product
    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0032-2018·2017-10-25

    St. Jude Medical Recalls Merlin PCS 3650 Programmer for Firmware Update

    St. Jude Medical is recalling 10,453 Merlin PCS 3650 programmers worldwide to install new firmware that mitigates the risk of unauthorized access to pacemakers.

    Product
    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0038-2018·2017-10-25

    St Jude Medical Recalls Pacemakers for Firmware Security Update

    St Jude Medical is recalling 2,726 implantable pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0033-2018·2017-10-25

    St. Jude Medical Recalls Merlin@Home Software for Pacemaker Security

    St. Jude Medical is recalling Merlin@Home software to mitigate the risk of unauthorized access to pacemakers using radio frequency communications.

    Product
    Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0030-2018·2017-10-25

    St Jude Medical Recalls Pacemakers for Unauthorized Access Risk

    St Jude Medical is recalling specific Assurity and Accent pacemaker models to mitigate the risk of unauthorized access via radio frequency communications.

    Product
    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated i
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·16191·2016-06-09

    Rhino Metals Recalls Bighorn Handgun Safes Due to Security Flaw

    Rhino Metals is recalling Bighorn P-20 handgun security safes because they can be opened without a combination, posing a serious risk of injury to children and others.

    Product
    Bighorn handgun security safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V461000·2015-07-23

    Chrysler Recalls 2013-2015 Vehicles for Radio Software Vulnerability

    Chrysler is recalling specific 2013-2015 Ram, Jeep, Dodge, and Chrysler vehicles because radio software vulnerabilities allow unauthorized remote access to vehicle control systems, increasing crash risk.

    Product
    RAM — RAM, JEEP, DODGE 5500, 1500, CHEROKEE, VIPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2015·2015-04-29

    Hospira LifeCare PCA Infusion System Recalled for Door Design Flaw

    Hospira is recalling 38,882 LifeCare PCA infusion systems because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.

    Product
    The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1517-2015·2015-04-29

    Hospira PCA 3 Infusion Pump Recalled for Door Design Flaw

    Hospira is recalling 8,214 PCA 3 infusion pumps because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.

    Product
    The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0422-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medi
    Category
    Medical Device
    Distribution
    Distributed nationwide