💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
All Recalls
95,094 total recalls in our database
💊 Drugs Class I - Dangerous
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specifications
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
🏥 Medical Devices Class I - Dangerous
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
🏥 Medical Devices Class I - Dangerous
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
🏥 Medical Devices Class I - Dangerous
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
Sunrise Medical (US)
🏥 Medical Devices Class I - Dangerous
There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame.
🏥 Medical Devices Class I - Dangerous
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
AUTOCOMP6 XPS High Speed Compounder REF 58810
The Metrix Company
🏥 Medical Devices Class I - Dangerous
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
🏥 Medical Devices Class I - Dangerous
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
🏥 Medical Devices Class I - Dangerous
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
AUTOCOMP6 High Speed Compounder
The Metrix Company
🏥 Medical Devices Class I - Dangerous
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples
🏥 Medical Devices Class I - Dangerous
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
🏥 Medical Devices Class I - Dangerous
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
🏥 Medical Devices Class I - Dangerous
It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
AUTOCOMP6 XP High Speed Compounder REF 58810
The Metrix Company
🏥 Medical Devices Class I - Dangerous
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.