Medline Convenience Kits: 1) Chp Cochlear Supplement Cds, Model Number: Cds983069g; 2) Chp Cochlear Supplement Cds, Model Number: Cds983069i; 3) Head & Neck Cds-lf, Model Number: Cds983782c; 4)

Medline is recalling 70 different surgical convenience kits used in head, neck, ear, nose, and throat procedures because equipment used to sterilize and package them may not have been properly calibrated. This calibration issue could affect whether the products maintain their required sterility standards, even though they went through sterilization and packaging processes.

Product

Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT...

Reason

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Classification

Class I

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/fe7cfb79-0b3b-48d9-8965-70d464ec4183