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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68803

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

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Event summary

Timeline bucket
July 11, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Beevers Manufacturing & Supply, 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

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

Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.

Z-2181-2014
Recall number
Z-2181-2014
Initiated
July 11, 2014
Classification
Class II
Status
Terminated
Quantity
240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.

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

Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.

Code information

Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and LW105 (extra large), Lot 67879. LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.

Distribution pattern

Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.