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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81640

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

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Event summary

Timeline bucket
November 27, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medical Action Industries 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

Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.

Z-0681-2019
Recall number
Z-0681-2019
Initiated
November 27, 2018
Classification
Class II
Status
Terminated
Quantity
13 cases (2,600 sponges)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterile barrier

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

Potential compromise of product sterility due to breach of sterile barrier.

Code information

Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111

Distribution pattern

Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.