Facility

STRATASYS LTD

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

Key facts

1recalls · worst Class III

—inspections in our data

—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)	3016074824
Establishment type	Manufacture Medical Device
Location	10 Habarzel st Kiryat Gat Southern, IL 82583
Registration status	Active · expires 2026
Parent company	Stratasys Ltd (owner-operator 10086646)
Brand names	MED610; MED610-DSG

Activity by year

Recalls (1)

Devices registered here (1)

Accessories, Implant, Dental, Endosseous
Product code NDP (opens in a new tab) · Class I · Dental · 21 CFR 872.3980

Recalls & enforcement

Class IIICompleted2024-01-19
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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. “STRATASYS LTD (FEI 3016074824) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016074824-stratasys-ltd/

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