💊 Drugs Class I - Dangerous
Lack of sterility assurance: bag has the potential to leak.
All Recalls
95,025 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Subpotent Drug
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
🏥 Medical Devices Class I - Dangerous
Excessive ultraviolet-C radiation
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Wright Medical Technology
🏥 Medical Devices Class I - Dangerous
The package contents and package labeling do not match.
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Total Thyroxine (T4) ELISA; REF EIA-1781
DRG International
🏥 Medical Devices Class I - Dangerous
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
There is a potential for the outer white Tyvek lid to debond from the sealed package.
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Beeken Biomedical
🏥 Medical Devices Class I - Dangerous
Endotoxin levels exceeded allowable limits.
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
XXX
🏥 Medical Devices Class I - Dangerous
Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
🏥 Medical Devices Class I - Dangerous
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
🏥 Medical Devices Class I - Dangerous
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure