Medical Device

Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model

Recall date: 2026-05-13 · Source: FDA_DEVICE

Brand / Firm

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: DYNJ19529O; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 11) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 12) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 13) C-SECTION PACK, Model Number: DYNJ23544F; 14) C-SECTION PACK, Model Number: DYNJ32632F; 15) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 16) C-SECTION PACK, Model Number: DYNJ35902F; 17) C-SECTION PACK-LF, Model Number: DYNJ38801F; 18) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 19) C-SECTION, Model Number: DYNJ41444F; 20) C-SECTION PACK, Model Number: DYNJ49224I; 21) C-SECTION PACK, Model Number: DYNJ49771A; 22) C-SECTION PACK, Model Number: DYNJ49771B; 23) C SECTION PACK-LF, Model Number: DYNJ52387I; 24) C-SECTION PACK, Model Number: DYNJ53528B; 25) C SECTION PACK-LF, Model Number: DYNJ55367A; 26) C-SECTION PACK, Model Number: DYNJ56523C; 27) C-SECTION PACK, Model Number: DYNJ59387L; 28) C-SECTION PACK, Model Number: DYNJ59387M; 29) C-SECTION PACK, Model Number: DYNJ59387N; 30) C-SECTION PACK, Model Number: DYNJ59387O; 31) C-SECTION PACK, Model Number: DYNJ59387P; 32) C-SECTION TRAY, Model Number: DYNJ62707B; 33) C-SECTION PACK, Model Number: DYNJ64549B; 34) C SECTION PACK, Model Number: DYNJ67347A; 35) C SECTION PACK, Model Number: DYNJ69778A; 36) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 37) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 38) PAD C-SECTION, Model Number: DYNJ902134C; 39) RICH C-SECTION, Model Number: DYNJ902182J; 40) C-SECTION, Model Number: DYNJ902938J; 41) C-SECTION PACK, Model Number: DYNJ904329D; 42) OB DELIVERY KIT, Model Number: DYNJ904453C; 43) C-SECTION, Model Number: DYNJ904697F; 44) C-SECTION, Model Number: DYNJ906255B; 45) KIT C SECTION, Model Number: DYNJ906966G; 46) C SECTION, Model Number: DYNJ907999A; 47) KIT C SECTION OR, Model Number: DYNJ908350C; 48) C-SECTION, Model Number: DYNJ909058; 49) C SECTION, Model Number: DYNJ909475A; 50) C-SECTION PACK, Model Number: DYNJ909507; 51) C-SECTION, Model Number: DYNJ910199; 52) C-SECTION, Model Number: DYNJ910199A; 53) C SECTION TRAY, Model Number: DYNJT3407; 54) C-SECTION BASIN PACK, Model Number: OBP211C; 55) TR-C SECTION PACK-LF, Model Number: PHS583549002B

Reason for recall

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.

Units affected

12529 units

Description

View official recall notice →