CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report

SpinVision Sterile Equip cover II recalled by Volcano

Volcano is recalling SpinVision Sterile Equip cover II; Sterile, distributed nationwide in the US. The recall was initiated on 5 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF numbers: 891BG and 891BG-10 (10 pack): all lots

Quantity recalled1355 total

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-1042-2016
FDA event ID: 73254
Recalling firm: Volcano, Rancho Cordova, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Feb 2016
FDA classified: 3 Mar 2016
Reported: 9 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

5 Feb 2016	Recall initiated by company
3 Mar 2016	Classified by FDA	+27 days
9 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

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

Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

Where it was distributed

Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

REF numbers: 891BG and 891BG-10 (10 pack): all lots

Where was it sold?

Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 73254

This product is part of a recall event; the main page for the event is R100 Sterile Equipment Cover recalled by Volcano.

Reported	Class	Recall	Company	Reason	Where
9 Mar 2016	CLASS II	R100 Sterile Equipment Cover recalled by Volcano	Volcano	Sterility	Nationwide

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