MEDLINE IND: Medical Device Recall in 2017 - (Recall #: Z-0984-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

Product Classification:

Class II

Date Initiated: December 12, 2016

Date Posted: January 18, 2017

Recall Number: Z-0984-2017

Event ID: 75948

Reason for Recall:

Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.

Status: Terminated

Product Quantity: 12,024 tubes

Code Information:

Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada

Voluntary or Mandated:

Voluntary: Firm initiated