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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78058

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

Open FDA event record

Event summary

Timeline bucket
July 26, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Molnlycke Health Care, 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

7x10" Small Utility Positioner with Cover

Z-0416-2018
Recall number
Z-0416-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
960 units total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
metal shavings
Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specifications

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

Products may not meet specifications due to possible presence of metal shavings.

Code information

Recorder Code 1400227

Distribution pattern

Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

device · product 2 of 2

9x15" Medium Utility Positioner with Cover

Z-0417-2018
Recall number
Z-0417-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
204 units total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
metal shavings
Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specifications

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

Products may not meet specifications due to possible presence of metal shavings.

Code information

Recorder Code 1400239

Distribution pattern

Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.