Medline Industries, LP: Medical Device Recall in 2026 - (Recall #: Z-1409-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

Product Classification:

Class II

Date Initiated: January 7, 2026

Date Posted: February 25, 2026

Recall Number: Z-1409-2026

Event ID: 98329

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.

Status: Ongoing

Product Quantity: 240 units

Code Information:

1) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020; 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated