Device recall: Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031

Class II FDA enforcement event 86942. Recall start date: 2 Dec 2020. Status in the FDA record: Terminated. Termination date: 21 Jun 2022.

Reason for recall, in the words of FDA

Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch

Class II, in the words of FDA

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

Steris Corporation started this device recall on 2 Dec 2020. The firm address in the FDA record is in Mentor, OH. FDA put the recall in Class II. FDA event 86942 has 14 product records. The first FDA enforcement report date is 13 Jan 2021. The record gives the status Terminated, with the termination date 21 Jun 2022.

FDA enforcement report The 14 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Foreign:

Recalling firm

Steris Corporation, Mentor, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

14 product records in the event.

FDA event 86942: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0786-2021	Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031	7 cases	Class II	Terminated	13 Jan 2021
Z-0787-2021	Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041	65 units	Class II	Terminated	13 Jan 2021
Z-0788-2021	Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061	98 cases	Class II	Terminated	13 Jan 2021
Z-0789-2021	Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091	197 cases	Class II	Terminated	13 Jan 2021
Z-0790-2021	Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411	53 cases	Class II	Terminated	13 Jan 2021
Z-0791-2021	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610	54 cases	Class II	Terminated	13 Jan 2021
Z-0792-2021	Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713	31 cases	Class II	Terminated	13 Jan 2021
Z-0793-2021	Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039	170 cases	Class II	Terminated	13 Jan 2021
Z-0794-2021	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118	589 cases	Class II	Terminated	13 Jan 2021
Z-0795-2021	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411	43 cases	Class II	Terminated	13 Jan 2021
Z-0796-2021	Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510	229 cases	Class II	Terminated	13 Jan 2021
Z-0797-2021	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515	7 cases	Class II	Terminated	13 Jan 2021
Z-0798-2021	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713	201 cases	Class II	Terminated	13 Jan 2021
Z-0799-2021	Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816	46 cases	Class II	Terminated	13 Jan 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 14Median of the firm: 1
Events of the firm on the register: 58

Other events of the firm

Other FDA enforcement events of Steris Corporation
Initiated	Product (first record)	Type	Class	Records
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	1
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	2
19 Nov 2025	AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is	Device	Class II	2
23 Jun 2025	Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems	Device	Class II	2
23 May 2025	Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H	Device	Class II	1
13 Jun 2024	Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Autom	Device	Class II	4
12 Dec 2023	Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754	Device	Class II	2
16 Nov 2023	V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended	Device	Class II	1
13 Nov 2023	Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Mod	Device	Class II	1
10 Apr 2023	Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062	Device	Class II	1

Steris Corporation: all 58 events

Official channels

FDA enforcement report Z-0786-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 86942. https://recallregister.com/fda/ii/86942/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Foreign:
What quantity of product is in FDA event 86942?: The event has 14 product records. The first record gives this quantity: 7 cases
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.