Facility

EDWARDS LIFESCIENCES TECHNOLOGY SARL

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2648045
Establishment type	Manufacture Medical Device
Location	STATE ROAD 402, KM 1.4, Industrial Park ANASCO, PR, US 00610
Registration status	Active · expires 2026
Parent company	Becton, Dickinson and Company (owner-operator 10093301)
Brand names	Shear Force Gauge

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Catheter, Embolectomy
Product code DXE (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.5150

Recalls & enforcement

Class IIOngoing2026-08-11
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Class IIOngoing2026-04-08
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

FDA inspections (1)

VAI2019-06-11
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “EDWARDS LIFESCIENCES TECHNOLOGY SARL (FEI 2648045) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2648045-edwards-lifesciences-technology-sarl/

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