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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80160

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

Open FDA event record

Event summary

Timeline bucket
November 22, 2017
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
ECOLAB 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

ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

Z-2332-2018
Recall number
Z-2332-2018
Initiated
November 22, 2017
Classification
Class III
Status
Terminated
Recalling firm
ECOLAB INC
Quantity
65 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The incorrect IFU was shipped with the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The incorrect IFU was shipped with the product.

Code information

Lot numbers D151871, D151961, D161861, D162001, and D162911

Distribution pattern

US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.

device · product 2 of 2

ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

Z-2333-2018
Recall number
Z-2333-2018
Initiated
November 22, 2017
Classification
Class III
Status
Terminated
Recalling firm
ECOLAB INC
Quantity
65 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The incorrect IFU was shipped with the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The incorrect IFU was shipped with the product.

Code information

Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.

Distribution pattern

US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.