Medline E-Z Lubricating Jelly — Class II medical device recall Z-0984-2017
Terminated recall by MEDLINE IND, reported 2017-01-18, distributed nationwide. Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility
| Recall number | Z-0984-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE IND, Northfield, IL, United States |
| Recall initiated | 2016-12-12 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2019-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12,024 tubes |
| Lot numbers | 6I26 |
| Expiration dates | 2019-08 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0984-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.