North Carolina recalls

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

Lack of 510K clearance

Lack of 510K clearance

Knee and Humeral socket implants contain incorrect labeling.

Knee and Humeral socket implants contain incorrect labeling.

Knee and Humeral socket implants contain incorrect labeling.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.