🔍 RecallPedia

All Recalls

95,114 total recalls in our database

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28,983
Food
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17,685
Drugs
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38,779
Medical Devices
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9,667
Consumer Products

Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.

PROVIDENCE MEDICAL TECHNOLOGIES

🏥 Medical Devices Class I - Dangerous

There may be dimensional manufacturing error that represents a potential safety risk to patients.

Mar 29, 2019 Implants & Prosthetics Nationwide View Details →

HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Coltene Whaledent

🏥 Medical Devices Class I - Dangerous

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

Jun 3, 2020 Other Medical Devices View Details →

ADVIA Chemistry Calibrator

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

Jun 5, 2020 Other Medical Devices Nationwide View Details →

HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Coltene Whaledent

🏥 Medical Devices Class I - Dangerous

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

Jun 3, 2020 Other Medical Devices View Details →

Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system

Hocoma AG

🏥 Medical Devices Class I - Dangerous

The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.

Jun 8, 2020 Diagnostic Equipment Nationwide View Details →

CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-001-053034 2042084-001-215165 2042084-001-079462 2042084-001-047389 2042084-001-112198 2042084-001-041673 2042084-001-227238 2042084-001-071564 2042084-001-503824 2042084-001-119839 2042084-001-569269 2042084-001-041674 2042084-001-047549 2042084-001-514651 2042084-001-163572 2042084-001-583721 2042084-001-427592 2042084-001-527358 2042084-001-583723 2042084-001-317166 2042084-001-583724 2042084-001-583715 2042084-001-583718 2042084-001-055156 2042084-001-583722 2042084-001-041835 2042084-001-074124 2042084-001-583706 2042084-001-583707 2042084-001-519926 2042084-001-583717 2042084-001-583713 2042084-001-207863 2042084-001-460604 2042084-001-079192 2042084-001-197663 2042084-001-045872 2042084-001-053195 2042084-001-092010 2042084-001-560824 2042084-001-052372 2042084-001-071088 2042084-001-046667 2042084-001-213006 2042084-001-086202 2042084-001-301821 2042084-001-045720 2042084-001-060454 2042084-001-418294 2042084-001-088907 2042084-001-065769 2042084-001-589530 2042084-001-623792 2042084-001-187563 2042084-001-320333 2042084-001-357143 2042084-001-148302 To be provided 2042084-001-082825 2042084-001-057016 2042084-001-153601 2042084-001-161552 2042084-001-140229 2042084-001-611704 2042084-001-626688 2042084-001-389208 2042084-001-657836 2042084-001-225214 2042084-001-503162 2042084-001-477881 2042084-001-316025 2042084-001-046826 2042084-001-245255 2042084-001-196543 2042084-001-557725 2042084-001-505890 2042084-001-218596 2042084-001-336980 2042084-001-524525 2042084-001-600032 2042084-001-529732 2042084-001-195742 2042084-001-195782 2042084-001-573889 2042084-001-573890 2042084-001-573886 2042084-001-573887 2042084-001-195822 2042084-001-195862 2042084-001-048420 2042084-001-065538 2042084-001-055814 2042084-001-341260 2042084-001-149220 2042084-001-079193 2042084-001-229282 2042084-001-629486 2042084-001-058695 2042084-001-061170 2042084-001-629548 2042084-001-080803 2042084-001-596662 2042084-001-250146 2042084-001-202515 2042084-001-515709 2042084-001-579491 2042084-001-505608 2042084-001-065010 2042084-001-619171

GE Healthcare

🏥 Medical Devices Class I - Dangerous

The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.

May 18, 2020 Diagnostic Equipment View Details →

RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

RAYSEARCH LABORATORIES AB

🏥 Medical Devices Class I - Dangerous

It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

May 26, 2020 Other Medical Devices View Details →

Oscar 2, Model 250 System

Suntech Medical

🏥 Medical Devices Class I - Dangerous

The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.

Apr 20, 2020 Other Medical Devices Nationwide View Details →

Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

Merge Healthcare

🏥 Medical Devices Class I - Dangerous

An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.

May 8, 2020 Infusion Pumps Nationwide View Details →

HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Coltene Whaledent

🏥 Medical Devices Class I - Dangerous

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

Jun 3, 2020 Other Medical Devices View Details →

Atellica CH Chemistry Calibrator

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

Jun 5, 2020 Other Medical Devices Nationwide View Details →