Device recall: 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/

FDA enforcement event 80160 · Class III · initiated 22 Nov 2017 · status Terminated · terminated 22 Jul 2020

DeviceVoluntary: Firm initiated2 product recordsSaint Paul, MN

ECOLAB INC (Saint Paul, MN) initiated this device recall on 22 Nov 2017; FDA lists 2 product records under event 80160, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 22 Jul 2020. Initiation: voluntary: firm initiated. ECOLAB INC has 14 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ECOLAB INC, Saint Paul, MN.

Reason for recall

"The incorrect IFU was shipped with the product."

Distribution

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

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2332-2018	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…	65 cases	Class III	Terminated	11 Jul 2018
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, 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…	65 cases	Class III	Terminated	11 Jul 2018

Context

4%of 2017 device events are Class III1,091 events that year

2product records in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for ECOLAB INC

Initiated	Product (first record)	Type	Class	Records
11 Jan 2021	Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended	Device	Class II	1
30 Jul 2020	Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, N	Drug	Class II	1
10 May 2019	QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Pa	Drug	Class III	1
6 Feb 2019	Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz	Drug	Class II	5
9 Nov 2018	Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street	Drug	Class II	2
14 Sep 2018	Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Int	Device	Class II	4
13 Oct 2017	Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches a	Device	Class II	1
2 Dec 2016	Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-	Drug	Class III	1
30 Nov 2016	Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.	Device	Class III	1
14 Jul 2016	Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shi	Device	Class II	1

All 14 events for ECOLAB INC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The incorrect IFU was shipped with the product."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Jul 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.