Medline Convenience Kits: 1) Spinal Cds, Model Number: Cds940087ag; 2) Spinal Cds, Model Number: Cds940087ai; 3) Total Hip Cds-lf, Model Number: Cds980832q; 4) Total Hip Cds-lf, Model Number: C

Recall Summary Medline is recalling multiple surgical convenience kits used in orthopedic and neurosurgical procedures due to calibration issues with the sterilization and packaging equipment. The affected products may not meet required sterility standards, even though they went through sterilization processes. This recall affects healthcare facilities that received these kits.

Product

Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K;...

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/dc6a328c-c652-44db-bcac-b152755055e7