Medline Convenience Kits: 1) C-section Pack, Model Number: Cds820080n; 2) C-section Cds, Model Number: Cds983523g; 3) C-section, Model Number: Cdsccr611o; 4) C-section, Model Number: Cdsccr611p

Medline is recalling 36 models of C-section convenience kits used in hospitals because equipment used to sterilize and package these kits may not have been properly calibrated, which could affect whether the products are adequately sterile. The recall affects medical facilities that received these kits, identified by various model numbers starting with CDS or DYNJ prefixes. This is classified as a Class II recall, meaning there is a potential health risk but the products are unlikely to cause serious injury.

Product

Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK,...

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 II

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/46fd0b32-f554-4340-b4a6-dd115f40761d