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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

AVID Medical Halyard IV Start Kits

Halyard IV Start Kit NON-Sterile may have an open or incomplete seal on the applicator packaging.

Moderate risk, FDA, Packaging defect

1 recall

Cardinal Health 200 Presource Convenience Kits

Presource Convenience Kits contain applicators with open or incomplete seals, which could cause infection.

Moderate risk, FDA, Contamination

1 recall

Medical Action Blood Culture Collection Kits

Medical Action Blood Culture Collection Kits contain applicators with an open or incomplete seal that may compromise sterility and lead to infection.

Moderate risk, FDA, Sterility problem

1 recall

Medline Convenience Kits with BD ChloraPrep Applicators

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators may have an open or incomplete seal, leading to infection.

Moderate risk, FDA, Contamination

1 recall

Zimmer Biomet Intramedullary Bone Saw Blade Assembly

The Intramedullary Bone Saw Blade Assembly may have damaged sterile barrier packaging due to an exposed saw blade.

Moderate risk, FDA, Sterility problem

1 recall

AMS Aligned Medical Solutions Medical Convenience Kits

Medical convenience kits contain Lidocaine HCl injection that may be affected by supplier quality issues.

Moderate risk, FDA, Packaging defect

1 recall

Medline Kits Containing Zimmer Biomet Mixing Bowls and Spatulas

Medline kits with Zimmer Biomet mixing bowls and spatulas have seal nonconformities risking sterility breach.

Moderate risk, FDA, Sterility problem

1 recall

Encore Medical EMPOWR 3D Knee Implants

The knee device has a packaging discrepancy with incorrect product size mixed up.

Moderate risk, FDA, Packaging defect

1 recall

Merit Medical Systems Splashwire Hydrophilic Guide Wire

The Splashwire Hydrophilic Guide Wire has unsealed portions of pouches.

Moderate risk, FDA, Packaging defect

1 recall

Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters

Reprocessed electrophysiology catheters have incomplete seals on sterile product.

Moderate risk, FDA, Sterility problem

1 recall

Zimmer Disposable Mixing Bowls with Spatula

Disposable Mixing Bowls with Spatula may have incomplete or peeling seals, which could lead to infection.

Moderate risk, FDA, Sterility problem

1 recall

MediHoney Gel and Calcium Alginate Dressings

MediHoney dressings and gel may have packaging failures that could breach the sterile barrier.

Moderate risk, FDA, Sterility problem

1 recall

Halyard Transport Bag Kit

The Halyard TRANSPORT BAG KIT has a Tyvek bag seal issue that may compromise sterility.

Moderate risk, FDA, Sterility problem

1 recall

Encore Medical EMPOWR Knee and Hip Implants

Empowr Acetabular System and Empowr 3D Knee Tibial Insert may have a packaging discrepancy that could cause surgical delay or revision surgery.

Moderate risk, FDA, Packaging defect