FDAJune 27, 2022device
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device may potentially cause a fire, leading to a safety risk.
What to do
FDA enforcement status: Ongoing
Brands named
davol
UPCs
00801741010118
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAvitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.2026-03-25
- FDAVentralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 59554602023-04-25
- FDAVentralight ST w EchoPS 4"x6" Ellipse- 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: 5955460G (EU Only)2023-04-25
- FDAVentralight ST w Echo PS 4.5" Circle 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: 5955450G (EU only)2023-04-25
- FDAVentralight 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: 59554502023-04-25
- FDAHydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 00268702022-06-07
- FDAHydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 00268802022-06-07
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