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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61899

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

Open FDA event record

Event summary

Timeline bucket
May 14, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hartmann USA, 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

Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing

Z-1857-2012
Recall number
Z-1857-2012
Initiated
May 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Hartmann USA, Inc
Quantity
Lot 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

Code information

Item # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397

Distribution pattern

Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.

device · product 2 of 2

Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing

Z-1858-2012
Recall number
Z-1858-2012
Initiated
May 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Hartmann USA, Inc
Quantity
Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

Code information

Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394

Distribution pattern

Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.