Medline Industries, LP: Medical Device Recall in 2026 - (Recall #: Z-1398-2026)

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) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;

Product Classification:

Class II

Date Initiated: January 7, 2026

Date Posted: February 25, 2026

Recall Number: Z-1398-2026

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: 808 units

Code Information:

1) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23FDC392; 2) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDB552; 3) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDA474; 4) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 22LDA486; 5) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24KDB955; 6) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24IDB525; 7) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24GDB922; 8) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24FDB302; 9) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24EDB468; 10) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24DDB769; 11) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB829; 12) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB327; 13) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDA984; 14) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 23HDB637

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated