Dr — Class II medical device recall Z-1953-2015
Terminated recall by Sheffield Pharmaceuticals, LLC, reported 2015-07-08, distributed in CA, FL, GA, IL, KS, MI, MN, NC…. Recovery of high count of gram positive rods including single colonies of B. cepacia.
| Recall number | Z-1953-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sheffield Pharmaceuticals, LLC, New London, CT, United States |
| Recall initiated | 2015-04-27 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2016-06-10 |
| Distributed | CA, FL, GA, IL, KS, MI, MN, NC, NJ, NY, PR |
| Countries outside the US | JM |
| Quantity | 37,636 units |
| Pathogens | burkholderia |
| Lot numbers | 01/18, 40131, 40132, 40141 |
Product
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Reason for recall
Recovery of high count of gram positive rods including single colonies of B. cepacia.
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-1953-2015. 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.