The Recall Desk
SevereFDA (Devices)·Z-0984-2017·Announced 2017-01-18

Medline E-Z Lubricating Jelly Recalled Due to Lack of Sterilization

Medline is recalling 12,024 tubes of E-Z Lubricating Jelly because they were not sterilized due to a shipping error.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The failure to sterilize a product intended for insertion into body orifices poses a significant risk of infection, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.

Plain-English summary

Medline Industries is recalling 12,024 tubes of Medline E-Z Lubricating Jelly, 2 FL OZ (59 ml). The product is a bacteriostatic, water-soluble, sterile lubricant intended for medical use to facilitate the entry of diagnostic or therapeutic devices into body orifices. The specific lot number is 6I26, with a unit number of MDS032285 and an expiration date of 08/2019.

The recall was initiated because the product was not sterilized. According to the source text, an operations error by a third-party shipping company caused the product to be shipped to distribution centers instead of the sterilization facility. This means the recalled units may not be sterile, despite the packaging indicating they are sterile if unopened and undamaged.

The affected product was distributed worldwide, including nationwide in the United States in the states of Alabama, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Michigan, Pennsylvania, Texas, and Wisconsin, as well as in Canada. Consumers and healthcare providers should stop using the recalled product and contact Medline Industries for further instructions or a replacement.

The recalled product

Product
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.
Manufacturer
MEDLINE IND
Category
Medical Device — Lubricants
Hazard
Affected units
12,024

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Related recalls

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