💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
All Recalls
95,025 total recalls in our database
💊 Drugs Class I - Dangerous
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed Stability Specification
💊 Drugs Class I - Dangerous
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
MicroScan WalkAway-40 plus Instrument REF B1018-283
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
🏥 Medical Devices Class I - Dangerous
The device was not cleared for U.S. distribution.
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
🏥 Medical Devices Class I - Dangerous
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Radiometer Medical ApS
🏥 Medical Devices Class I - Dangerous
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
🏥 Medical Devices Class I - Dangerous
ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system breach, which presents the possibility of cross-contamination where the potential contaminations are well known API's at well below efficacious dose levels.
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Firm discovered a firmware memory leak with a supplier-manufactured component.
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Getinge Usa Sales
🏥 Medical Devices Class I - Dangerous
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
🏥 Medical Devices Class I - Dangerous
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Bio-Rad Laboratories
🏥 Medical Devices Class I - Dangerous
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Heartware
🏥 Medical Devices Class I - Dangerous
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Clinician's Choice Dental Products
🏥 Medical Devices Class I - Dangerous
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
🏥 Medical Devices Class I - Dangerous
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
🏥 Medical Devices Class I - Dangerous
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.