FDA Device recall Z-0984-2017
Medline E-Z Lubricating Jelly
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of Medline E-Z Lubricating Jelly by Medline Ind, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0984-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-12 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medline Ind |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0984-2017%22
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