CLASS III Device recall · Reported 11 Jul 2018 · FDA Enforcement Report

Microtek Rolled Probe Cover recalled by ECOLAB

Ecolab is recalling Microtek Rolled Probe Cover (, distributed in California, Illinois, Louisiana, South Carolina, Texas, Wisconsin. The recall was initiated on 22 Nov 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot numbers D151871, D151961, D161861, D162001, and D162911

Quantity recalled65 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2332-2018
FDA event ID: 80160
Recalling firm: Ecolab, Saint Paul, MN
Classification: Class III
Status: Terminated
Recall initiated: 22 Nov 2017
FDA classified: 29 Jun 2018
Reported: 11 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

22 Nov 2017	Recall initiated by company
29 Jun 2018	Classified by FDA	+219 days
11 Jul 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The incorrect IFU was shipped with the product.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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).

Where it was distributed

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

California Illinois Louisiana South Carolina Texas Wisconsin

Questions about this recall

Why was it recalled?

The incorrect IFU was shipped with the product.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 80160

This product is part of a recall event; the main page for the event is Microtek Rolled Probe Cover recalled by ECOLAB.

Reported	Class	Recall	Company	Reason	Where
11 Jul 2018	CLASS III	Microtek Rolled Probe Cover recalled by ECOLAB	Ecolab	Packaging Defects	6 states

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