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.
28,535 detailed records are currently available in this category.
Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to…
Edits to Particle field definition parameters may not be saved when the field definition window is saved.
BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot…
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21%…
BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front…
The black plastic puck on the carry bar is breaking resulting in potential for patient harm.
neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at…
Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version…
GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage…
The LightCycler 480 algorithm used for the LightMix Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there…
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our…
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be…
Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to…
Software update that provides software and firmware bug-fixes to improve system performance
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Device can fail during operation.
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.
