CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report
Ventralight ST 4.5" Circle with Echo PS- A low profile recalled by Davol
Davol is recalling Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent, 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-2242-2023
- 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
- Surgical Instruments
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 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
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.
Questions about this recall
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: Lot Number HUGS0922 HUGS2026 HUGS2061 HUGS2020 HUGS2044 HUGS2015 HUGS2076 HUGT1582 HUGU0750 HUGU0748
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 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
3 other products · FDA event 92213This product is part of a recall event; the main page for the event is Ventralight ST w Echo PS 4.5" Circle A low profile recalled by Davol.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ventralight ST w Echo PS 4.5" Circle A low profile recalled by Davol | Davol | Device Malfunction | Nationwide | |
| CLASS II | Ventralight ST w EchoPS 4"x6" Ellipse- A low profile recalled by Davol | Davol | Device Malfunction | Nationwide | |
| CLASS II | Ventralight ST 4" x 6" Ellipse with Echo PS recalled by Davol | Davol | Device Malfunction | Nationwide |
More recalls from Davol
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Avitene Ultrafoam Microfibrillar Collagen Hemostat recalled by Davol | Davol | Foreign Material | Nationwide |
| Device | CLASS II | Ventralight ST 4" x 6" Ellipse with Echo PS 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 4.5" Circle A low profile recalled by Davol | Davol | Device Malfunction | Nationwide |
| Device | CLASS II | X-Stream Irrigation System recalled by Davol | Davol | Other | Nationwide |
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 |