🔍 RecallPedia

All Recalls

95,075 total recalls in our database

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28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,628
Consumer Products

XLTEK EMU40EX EEG Headbox

Natus Neurology

🏥 Medical Devices Class I - Dangerous

Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.

May 15, 2018 Other Medical Devices Nationwide View Details →

1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

Galt Medical

🏥 Medical Devices Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Surgical Instruments View Details →

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

Merge Healthcare

🏥 Medical Devices Class I - Dangerous

The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

Aug 7, 2017 Diagnostic Equipment Nationwide View Details →

Discovery MI Digital Ready

GE Healthcare

🏥 Medical Devices Class I - Dangerous

DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

Galt Medical

🏥 Medical Devices Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Surgical Instruments View Details →

MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Jun 29, 2018 Diagnostic Equipment Nationwide View Details →

Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

Galt Medical

🏥 Medical Devices Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Other Medical Devices View Details →

Optima CT 520

GE Healthcare

🏥 Medical Devices Class I - Dangerous

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

Optima CT 540

GE Healthcare

🏥 Medical Devices Class I - Dangerous

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

Nicolet¿ Ambulatory EEG

Natus Neurology

🏥 Medical Devices Class I - Dangerous

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

Feb 1, 2018 Other Medical Devices Nationwide View Details →

1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

Galt Medical

🏥 Medical Devices Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Other Medical Devices View Details →

1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;

Galt Medical

🏥 Medical Devices Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Other Medical Devices View Details →