Food, drugs, devices › Davol, Inc., Subs. C. R. Bard, Inc.
Device recall: Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a
FDA enforcement event 63069 is a device recall by Davol, Inc., Subs. C. R. Bard, Inc. of Warwick, RI, initiated 4 Sep 2012 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 3 Sep 2013. Initiation: voluntary: firm initiated. Davol, Inc., Subs. C. R. Bard, Inc. has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Davol, Inc., Subs. C. R. Bard, Inc., Warwick, RI.
Reason for recall
"Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh"
Distribution
"Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2412-2012 | Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue… | 49 units | Class II | Terminated | 26 Sep 2012 |
| Z-2413-2012 | Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue… | 49 units | Class II | Terminated | 26 Sep 2012 |
Context
Other enforcement events for Davol, Inc., Subs. C. R. Bard, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Oct 2014 | Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists | Device | Class II | 1 |
| 24 Apr 2014 | Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, | Device | Class II | 15 |
| 3 Jan 2014 | Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non- | Device | Class II | 2 |
All 4 events for Davol, Inc., Subs. C. R. Bard, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Sep 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.