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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
Related recalls
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- SevereMedline Laceration Trays Recalled Due to Sterility Defect
FDA (Devices) · 2024-03-06
- HighMedline Recalls Sterile Elastic Esmark Bandages Due to Sterilization Failure
FDA (Devices) · 2018-01-03
- HighMedline Suction Catheters Recalled for Sterilization Error
FDA (Devices) · 2017-11-29
- HighMedline Esmark Elastic Bandages Recalled for Sterilization Failure
FDA (Devices) · 2014-05-28
- SevereMedline kits and trays recalled for potential lack of sterility
FDA (Devices) · 2024-03-06
- HighMedline Sterile Water and Saline Bottles Leaking at Seal Interface
FDA (Devices) · 2025-05-07