FDA Device recall Z-1953-2015
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant by Sheffield Pharmaceuticals, citing recovery of high count of gram positive rods including single colonies of B. cepacia.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1953-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-27 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sheffield Pharmaceuticals |
| Distribution | CA, FL, GA, IL, KS, MI, MN, NC, NJ, NY, PR |
Product
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Reason
Recovery of high count of gram positive rods including single colonies of B. cepacia.
Identifiers
| code_info | Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1953-2015%22
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