Facility

BELLCO Srl

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

Key facts

3recalls · 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)	1000312731
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	via Camurana, 1 Mirandola Modena, IT 41037
Registration status	Active · expires 2026
Parent company	Mozarc Medical US LLC (owner-operator 10090982)

Activity by year

Recalls (3)

Devices registered here (1)

Syringe, Piston
Product code FMF (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5860

Recalls & enforcement

Class IIOngoing2026-04-29
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Class IIOngoing2025-10-17
A potential issue with the seal integrity of header bag packaging.
Class IIOngoing2025-04-23
Potential breach of sterile barrier packaging.

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. “BELLCO Srl (FEI 1000312731) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000312731-bellco-srl/

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