Mozarc Medical US LLC
3 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (3)
Registered facilities (3)
- BELLCO Srl FEI 1000312731 · IT
- MOZARC MEDICAL US LLC FEI 3030574705 · MA
- Mozarc Medical Italy FEI 3043804021 · IT
Recalls & enforcement
- Class IIOngoing2026-04-29The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
- Class IIOngoing2025-10-17A potential issue with the seal integrity of header bag packaging.
- Class IIOngoing2025-04-23Potential 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. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Mozarc Medical US LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10090982-mozarc-medical-us-llc/
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