Medline Industries, LP: Medical Device Recall in 2026 - (Recall #: Z-1396-2026)

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) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

Product Classification:

Class II

Date Initiated: January 7, 2026

Date Posted: February 25, 2026

Recall Number: Z-1396-2026

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: 23238 units

Code Information:

1) DYKE1455B, UDI-DI: 10193489760781(each), 40193489760782(case), Lot Number: 22IBV801; 2) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23KMC417; 3) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23IMF495; 4) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23HMG566; 5) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMF416; 6) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMC067; 7) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23EMF635; 8) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMG332; 9) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMC558; 10) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMB706; 11) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23BMC768; 12) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22LMF786; 13) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22JMC784; 14) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22HMD809; 15) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22GMH729; 16) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMH954; 17) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMD365; 18) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMI534; 19) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMH737; 20) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21KBP287; 21) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21IBL687; 22) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH946; 23) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH534; 24) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21BBK795

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated