Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
26,628 detailed records are currently available in this category.
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a…
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient…
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient…
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826…
Instructions for Use booklets were not included on the outer pouch
Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acquired…
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Instructions for Use booklets were not included on the outer pouch
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the…
The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending…
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and…
Potential electric leakage affecting the user.
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
