FDA Medical Device Recalls (openFDA)
Volcano Corporation: Volcano R100 Sterile Equipment Cover; 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.
- Recall number
- Z-1041-2016
- Recalling firm
- Volcano Corporation
- Product
- Volcano R100 Sterile Equipment Cover; 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.
- Status
- Terminated
- Initiated
- 2016-02-05
- Posted
- 2016-03-03
- Terminated
- 2017-03-21
- Reason
- 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.
- Root cause
- Labeling False and Misleading
- Action
- Urgent Medical Device letters were sent to affected consignees the week of February 8, 2016 by Fed Ex or UPS so delivery can be tracked. For OUS consignees, the same letter will be sent and they will execute delivery to customers and track responses.
- Quantity
- 1355 total
- Distribution
- Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
- Lot, serial or model codes
- REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
- 510(k) numbers
- ["K052395"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 2939520
- Firm city
- Rancho Cordova
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28