CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report
Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number recalled
Davol, Inc., Subs. C. R. Bard is recalling Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in, distributed nationwide in the US. The recall was initiated on 24 Apr 2014 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-1695-2014
- FDA event ID
- 68124
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Warwick, RI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2014
- FDA classified
- 2 Jun 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Apr 2014 | Recall initiated by company | |
| 2 Jun 2014 | Classified by FDA | +39 days |
| 11 Jun 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
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
Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM
Questions about this recall
Is Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in recalled?
Yes. Davol, Inc., Subs. C. R. Bard recalled Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in on 24 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1695-2014.
Why was it recalled?
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Which lots are affected?
Lot Number: HUXK0058
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Davol, Inc., Subs. C. R. Bard
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is recalled | Davol, Inc., Subs. C. R. Bard | Packaging Defects | 8 states |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" recalled | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh with Echo PS" 5" Circle recalled | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh recalled by Davol, Inc., Subs. C. R. Bard | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" recalled | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
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