Medline Industries Recalls C-Section Convenience Kits Due to Sterility Assurance Concerns

FDA Recalls high FDA · · United States

Medline Industries, LP has voluntarily recalled over 4,500 C-Section convenience kits and trays because equipment calibration issues may have compromised product sterility.

What Happened

Medline Industries, LP has initiated a voluntary recall of various C-Section convenience kits and trays. The company identified calibration issues with the equipment used to sterilize and package these medical devices. While the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the affected units.

Which Products Are Affected

The recall involves 4,525 units distributed nationwide in the U.S. and worldwide. Affected products include 36 different model configurations, including but not limited to:

  • C-SECTION PACK: Models CDS820080N, DYNJ23544F, DYNJ32632F, DYNJ38801F, DYNJ49224I, DYNJ56523C, DYNJ59387L, DYNJ64549B, DYNJ904329D, DYNJ909507
  • C-SECTION TRAY: Models DYNJ15494G, DYNJ19529P, DYNJ19529Q, DYNJ19529R, DYNJ19529S, DYNJT3407
  • C-SECTION CDS: Model CDS983523G
  • C-SECTION: Models CDSCCR611O, CDSCCR611P, DYNJ41444F, DYNJ904697F, DYNJ907999A, DYNJ909058
  • LUD C-SECTION-LF: Model DYNJ0101616I
  • C-SECTION PACK-LF: Models DYNJ21550Q, DYNJ35100I
  • SCRIPPS SW C-SECTION PACK-LF: Model DYNJ40129C
  • C SECTION PACK-LF: Model DYNJ52387I
  • C SECTION PACK: Models DYNJ67347A, DYNJ69778A
  • B-C SECTION BAYSTATE: Models DYNJ900602I, DYNJ900602K
  • PAD C-SECTION: Model DYNJ902134C
  • RICH C-SECTION: Model DYNJ902182J
  • KIT C SECTION: Model DYNJ906966G
  • TR-C SECTION PACK-LF: Model PHS583549002B

Specific lot numbers and UDI-DI codes are associated with this recall. Notable lot numbers include 23IMB818, 23IBS984, 21WBA953, and 22IBG757, among others.

What You Should Do

Medline began notifying customers of the recall via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model and lot numbers. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For more information, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

Sterility is essential for surgical kits used in C-section procedures. If the sterility assurance level is compromised, there is an increased risk of infection for patients undergoing surgery.

Source

This information is based on an official recall notice from the FDA under recall number Z-1417-2026.

Source: FDA Official Notice

Related Articles

Centinel Spine Recalls Prodisc C SK Cervical Disc Replacement Devices Due to Mislabeled Sizing

FDA · March 4, 2026

Medline Industries Recalls 154,427 Convenience Kits Over Sterility Concerns

FDA · March 4, 2026

Medline Industries Recalls Chest/Breast Convenience Kits Due to Sterility Concerns

FDA · March 4, 2026