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St. Jude Medical, Cardian Rhythm Management Division

St. Jude Medical, Cardian Rhythm Management Division Recalls

All product recalls associated with St. Jude Medical, Cardian Rhythm Management Division.

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Recall Summary

Total Recalls

1000

Past Year

579

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3321–3340 of 10937 recalls

Assurity Pulse Generator (St. Jude Medical) – Epoxy Manufacturing Issue (2021)

Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

Moderate

FDAMar 15, 2021Nationwide• St. Jude Medical, Cardian Rhythm Management Division

Endurity Pulse Generator (St. Jude Medical) – Epoxy Manufacturing Issue (2021)

Moderate

FDAMar 15, 2021Nationwide• St. Jude Medical, Cardian Rhythm Management Division

MiniMed 780G Insulin Pump (Medtronic) – Software Fault Risk (2021)

Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.

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Moderate

FDAMar 15, 2021AR, CA, CO +9 more• Medtronic Minimed

MiniMed 670G Insulin Pump (Medtronic) – Software Fault Risk (2021)

Moderate

FDAMar 15, 2021AR, CA, CO +9 more• Medtronic Minimed

HydraVision Imaging System (Liebel-Flarsheim) – Performance Standard Failure (2021)

Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.

Moderate

FDAMar 11, 2021Nationwide• LIEBEL-FLARSHEIM COMPANY LLC

Coffee Toffee Chocolate Bar (Mindo) – undeclared milk (2021)

Undeclared Milk

Undeclared milk

Class IIModerate

FDAMar 11, 2021IN, MI• Mindo Chocolate Makers LLC

6-Foot Seminar Tables (Lifetime) – injury risk (2021)

This recall involves Lifetime Products 6-Foot Seminar Tables with model #80176. The tables have gray metal frames and white plastic tops. The tables measure 6 feet long by 18 inches wide by 28 inches high. The "Lifetime" logo is molded into each end of the upper surface of the table top. A green product ID sticker located on the underside of the table has the model number and the year and chronological day of manufacture in the first five digits (Example: June 23, 2020 = 20175), followed by a two-digit number for the factory. The recalled tables were manufactured between August 7, 2016 (16220) and June 23, 2020 (20175).

Moderate

CPSCMar 10, 2021Nationwide• Kingtec Group Vietnam Co. LTD, of Ben Cat Town, of Binh Duong Province, Vietnam

A610 Clinician Programmer Application for Deep Brain Stim... (Medtronic Neuromodulation) – there are two issues within this corr... (2021)

There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.

Moderate

FDAMar 9, 2021Nationwide• Medtronic Neuromodulation

Sodium Chloride Irrigation (ICU Medical) – particulate matter (2021)

Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

Class IIModerate

FDAMar 9, 2021Nationwide• ICU Medical Inc

Ranger Recreational Off-Highway Vehicles (Polaris) – Crash Hazard (2021)

This recall involves Model Year 2020-2021 RANGER 1000, RANGER CREW 1000, RANGER XP 1000, and RANGER CREW XP 1000 recreational off-highway vehicles and Model Year 2020 ProXD 2000G, ProXD 2000G H, ProXD 4000G, and ProXD 4000G H off-road utility vehicles. The vehicles were sold in the following colors: black, blue, burgundy, camo, gray, green, orange, red, sand, tan, titanium, and white. The RANGER vehicles have three or six seats and the ProXD vehicles have two or four seats. The RANGER and ProXD vehicles have "POLARIS" stamped on the front grille. The model number and VIN are printed on a portion of the left rear frame (on the driver's side of the vehicle) under the cargo box.

Moderate

CPSCMar 4, 2021Nationwide• Polaris Inc., of Medina, Minn.

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use On... (RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden) – patient related messages created in r... (2021)

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

Low

FDAMar 3, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Medtronic Bio-Console 560 Extracorporeal Blood Pumping Co... (Medtronic Perfusion Systems) – burn hazard (2021)

Fire/Burn Risk

An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.

High

FDAMar 3, 2021Nationwide• Medtronic Perfusion Systems

Consist of a distal connection mechanism (either standard... (Terumo Cardiovascular Systems Corporation) – there is a potential for the stainles... (2021)

There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

Moderate

FDAMar 2, 2021Nationwide• Terumo Cardiovascular Systems Corporation

Synapse PACS - Radiological Image Processing System - Pro... (Fujifilm Medical Systems U.S.A., Inc.) – the wrong patient information may be ... (2021)

The wrong patient information may be displayed in the viewer or PowerJacket.

High

FDAMar 2, 2021Nationwide• Fujifilm Medical Systems U.S.A., Inc.