Device recall: Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches a

FDA enforcement event 78419 · Class II · initiated 13 Oct 2017 · status Terminated · terminated 22 Jul 2020

DeviceVoluntary: Firm initiated1 product recordSaint Paul, MN

Ecolab, Inc. (Saint Paul, MN) initiated this device recall on 13 Oct 2017; FDA lists 1 product record under event 78419, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% 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

"Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch."

Distribution

"Distributed domestically to Michigan."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0523-2018	Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system…	5,958 cases (50 per case)	Class II	Terminated	14 Feb 2018

Context

93%of 2017 device events are Class II1,091 events that year

1product record 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
22 Nov 2017	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/	Device	Class III	2
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: "Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed domestically to Michigan."

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.