CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report
Ventralight ST 4" x 6" Ellipse with Echo PS recalled by Davol
Davol is recalling Ventralight ST 4" x 6" Ellipse with Echo PS, distributed nationwide in the US. The recall was initiated on 25 Apr 2023 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-2241-2023
- FDA event ID
- 92213
- Recalling firm
- Davol, Warwick, RI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Apr 2023
- FDA classified
- 27 Jul 2023
- Reported
- 2 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2023 | Recall initiated by company | |
| 27 Jul 2023 | Classified by FDA | +93 days |
| 2 Aug 2023 | 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
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
Stores named: Walmart
Questions about this recall
Is Ventralight ST 4" x 6" Ellipse with Echo PS recalled?
Yes. Davol recalled Ventralight ST 4" x 6" Ellipse with Echo PS on 25 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-2241-2023.
Why was it recalled?
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Which lots are affected?
UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
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
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|---|---|---|---|---|---|
| Device | CLASS II | Avitene Ultrafoam Microfibrillar Collagen Hemostat recalled by Davol | Davol | Foreign Material | Nationwide |
| Device | CLASS II | Ventralight ST 5" Circle with Echo PS- A low profile recalled by Davol | Davol | Device Malfunction | Nationwide |
| Device | CLASS II | Ventralight ST w EchoPS 4"x6" Ellipse- A low profile recalled by Davol | Davol | Device Malfunction | Nationwide |
| Device | CLASS II | Ventralight ST w Echo PS 5" Circle A low profile recalled by Davol | Davol | Device Malfunction | Nationwide |
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