Facility

VITROLIFE SWEDEN AB

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

Key facts

1recalls · worst Class II

—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)	3003995932
Establishment type	Manufacture Medical Device
Location	Gustaf Werners Gata 2 Vastra Frolunda Vastra Gotaland, SE 42132
Registration status	Active · expires 2026
Parent company	VITROLIFE AB (owner-operator 9037178)
Brand names	OVOIL; OVOIL HEAVY

Activity by year

Recalls (1)

Devices registered here (1)

Media, Reproductive, Exempt
Product code QKI (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.6180

Recalls & enforcement

Class IITerminated2014-12-22
The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.

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. “VITROLIFE SWEDEN AB (FEI 3003995932) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003995932-vitrolife-sweden-ab/

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