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Davol, Inc. FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.Class IIMar 25, 2026Potential for product to contain foreign matter, confirmed t |
| Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removabClass IIApr 25, 2023Balloon may not inflate as intended. If the balloon does no |
| Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removabClass IIApr 25, 2023Balloon may not inflate as intended. If the balloon does no |
| Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removClass IIApr 25, 2023Balloon may not inflate as intended. If the balloon does no |
| Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460Class IIApr 25, 2023Balloon may not inflate as intended. If the balloon does no |
| X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)Class IIJun 27, 2022The device may potentially cause a fire, leading to a safety |
| HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction anClass IIJun 7, 2022The product is not able to provide irrigation. |
| HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and IrrClass IIJun 7, 2022The product is not able to provide irrigation. |