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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71129

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 27, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sheffield Pharmaceuticals, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

Z-1953-2015
Recall number
Z-1953-2015
Initiated
April 27, 2015
Classification
Class II
Status
Terminated
Quantity
37,636 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Recovery of high count of gram positive rods including single colonies of B. cepacia.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Recovery of high count of gram positive rods including single colonies of B. cepacia.

Code information

Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18

Distribution pattern

Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.