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.
All Recalls
95,114 total recalls in our database
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
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Thoratec
🏥 Medical Devices Class I - Dangerous
If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
GE Centricity Universal Viewer Zero Footprint Client
GE Healthcare
🏥 Medical Devices Class I - Dangerous
There is a potential to display incomplete patient imaging study.
🏥 Medical Devices Class I - Dangerous
Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Wright Medical Technology
🏥 Medical Devices Class I - Dangerous
The package contents and package labeling do not match.
Free-Standing and Slide-In Electric and Gas Ranges
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The ranges can tip over when a heavy object is placed on an open oven door and the anti-tip-over bracket is not secured to the wall or floor, posing a tip-over hazard and risk of burn injuries from hot food or liquids in cookware.
Children's robes
Mark of Fifth Avenue, of Harriman, N.Y.
🏠 Consumer Products Class II - Moderate
The children's robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Bed Assist Handles and Bed Assist Rail
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
When attached to an adult's bed, users can become entrapped within the bed rail or between the rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.