Z-2333-2018Class III

ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch...

Name: Z-2333-2018 ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch...
Creator: Ecolab Inc
Published: 2017-11-22
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2017-11-22 / Terminated / root cause: labeling and UDI

FDA source

ECOLAB INC began a recall of 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... on 2017-11-22. FDA classified it as Class III and gives the reason as "The incorrect IFU was shipped with the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2333-2018
Classification: Class III
Status: Terminated
Initiated: 2017-11-22
Posted: 2018-07-13
Terminated: 2020-07-22
Recalling firm: Microtek Medical LLC
Product: 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).
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: The incorrect IFU was shipped with the product.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The recalling firm issued letters dated November 21, 2017, informing the customer the incorrect IFU was shipped with the product and a correct version of the IFU is being provided with the letter. The consignee was requested to notify downstream customers to the user level and that a copy of the letter could be forwarded to enhance communication. A Recall Response Form was enclosed for completion to be returned via FAX or email as soon as possible. The letter also informs the consignee that the recalling firm will send additional replacement IFU's if they have product in inventory. For further questions, please call (651) 250-4385.
Quantity in commerce: 65 cases
Distribution: US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
Product codes and lots: Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2333-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2332-2018	Class III	Terminated	Voluntary: Firm initiated	2018-07-11	2018-06-29
Z-2333-2018	Class III	Terminated	Voluntary: Firm initiated	2018-07-11	2018-06-29

Product code IYO

K961029Class IIKiltex Probe CoverKiltex Corp. / cleared 1996-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)