Facility

XODUS MEDICAL, INC.

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

Key facts

1recalls · worst Class II

3inspections · 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)	1000221205
Establishment type	Manufacture Medical Device
Location	702 PROMINENCE DR. New Kensington, PA, US 15068
Registration status	Active · expires 2026
Parent company	XODUS MEDICAL, INC. (owner-operator 9010904)
Brand names	SutureSafe; Syringe Transfer Cup; Blue Safety Foam Block; Safety Stop; Scalpel Holder; Needle Counters

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Needle, Suturing, Disposable
Product code GAB (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

Class IITerminated2019-09-19
The sterile barrier of some devices may have been affected

FDA inspections (3)

NAI2026-02-06
No Action Indicated · Compliance: Devices
NAI2019-08-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-10-10
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

All facilities operated by XODUS MEDICAL, INC.

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. “XODUS MEDICAL, INC. (FEI 1000221205) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000221205-xodus-medical-inc/

Not open yet

Alerts for XODUS MEDICAL, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.