MOZARC MEDICAL US LLC
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
Devices registered here (1)
- Catheter, Peritoneal, Long-Term IndwellingProduct code FJS (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5630
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.
Related
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. “MOZARC MEDICAL US LLC (FEI 3030574705) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030574705-mozarc-medical-us-llc/
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