🔍 RecallPedia

All Recalls

95,025 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,578
Consumer Products

AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

Ansh Labs

🏥 Medical Devices Class I - Dangerous

Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated to remove Plasma as a "sample type" and to update the "limitation" section to include potential cross-reactivity with non-SARS-CoV2 strains.

Dec 18, 2020 Infusion Pumps Nationwide View Details →

CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000

Medtronic

🏥 Medical Devices Class I - Dangerous

Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.

Nov 12, 2020 Other Medical Devices Nationwide View Details →

All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 100-240V 50/60 Hz, 600 VA MOD - Affinity 30 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 50 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 70 GMDN - 40761 100-240V 50/60 Hz, 450 VA

Philips Ultrasound

🏥 Medical Devices Class I - Dangerous

The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.

Oct 27, 2020 Diagnostic Equipment Nationwide View Details →

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare

🏥 Medical Devices Class I - Dangerous

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Dec 10, 2020 Diagnostic Equipment View Details →

Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

Dec 2, 2020 Diagnostic Equipment Nationwide View Details →

Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

GE Healthcare

🏥 Medical Devices Class I - Dangerous

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Dec 10, 2020 Diagnostic Equipment View Details →

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.

Medtronic Neuromodulation

🏥 Medical Devices Class I - Dangerous

A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.

Nov 12, 2020 Implants & Prosthetics Nationwide View Details →