
AccuVu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...
Page 26 of 39 · 1,907 total recalls

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing...


Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Chemical contamination: Presence of benzene

Chemical contamination: Presence of benzene

Chemical contamination: Presence of benzene

Chemical contamination: Presence of benzene

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term...

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

Non-Sterility: microbial contamination identified as Paenibacillus phoenicis

Undeclared wheat.

Undeclared wheat and Yellow #6.

Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.
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