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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82971

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 08, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Madison Polymeric Engineering

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

2 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 2

Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z

Z-1924-2019
Recall number
Z-1924-2019
Initiated
May 08, 2019
Classification
Class II
Status
Terminated
Quantity
2723

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This product has been contaminated with Stenotrophomonas lactiubi.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This product has been contaminated with Stenotrophomonas lactiubi.

Code information

Lot Numbers EX20191121P EX20191126P EX20191127P EX20191212X EX20191213X EX20200125X

Distribution pattern

The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.

device · product 2 of 2

First Step Draco Pad, Product Number EP-4D

Z-1925-2019
Recall number
Z-1925-2019
Initiated
May 08, 2019
Classification
Class II
Status
Terminated
Quantity
10570

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This product has been contaminated with Stenotrophomonas lactiubi.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This product has been contaminated with Stenotrophomonas lactiubi.

Code information

Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X

Distribution pattern

The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.