Volcano Corporation: Medical Device Recall in 2016 - (Recall #: Z-1042-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 5, 2016

Date Posted: March 9, 2016

Recall Number: Z-1042-2016

Event ID: 73254

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.

Status: Terminated

Product Quantity: 1355 total

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated