CLASS III Device recall · Reported 11 Jul 2018 · FDA Enforcement Report
Microtek Rolled Probe Cover recalled by ECOLAB
ECOLAB is recalling Ecolab 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
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-2333-2018
- 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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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).
Where it was distributed
US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
Questions about this recall
Is Microtek Rolled Probe Cover recalled?
Yes. ECOLAB recalled Microtek Rolled Probe Cover on 22 Nov 2017. The recall is Class III and its status is Terminated. Recall number Z-2333-2018.
Why was it recalled?
The incorrect IFU was shipped with the product.
Which lots are affected?
Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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