CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report
R100 Sterile Equipment Cover recalled by Volcano
Volcano is recalling R100 Sterile Equipment Cover, 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
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-1041-2016
- 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 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.
Where it was distributed
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
REF numbers: PBKGB and PBKBG-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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SpinVision Sterile Equip cover II recalled by Volcano | Volcano | Sterility | Nationwide |
More recalls from Volcano
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips IntraSight Plus recalled by Volcano | Volcano | Device Malfunction | Nationwide |
| Device | CLASS II | Visions Digital IVUS Catheter: PV.014P (Platinum) recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS III | Visions PV. 035 Digital IVUS Catheter recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS III | Visions PV. 035 Digital IVUS Catheter recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS II | Philips OmniWire Pressure guide wire recalled by Volcano | Volcano | Sterility | WA, WI |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |