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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88088

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

Open FDA event record

Event summary

Timeline bucket
June 10, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mercedes Medical, Inc.

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

Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.

Z-2066-2021
Recall number
Z-2066-2021
Initiated
June 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
Mercedes Medical, Inc.
Quantity
6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
No 510(k) clearance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

No 510(k) clearance

Code information

All lots.

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas. Government distribution was made but no military distribution.

device · product 2 of 2

Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

Z-2067-2021
Recall number
Z-2067-2021
Initiated
June 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
Mercedes Medical, Inc.
Quantity
SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
No 510(k) clearance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

No 510(k) clearance

Code information

All lots.

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas. Government distribution was made but no military distribution.