The FDA has posted 12 enforcement recalls from Mozarc Medical US LLC since 2025, none of them Class I (most serious). Most recent report: Jun 17, 2026.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Firm name as filed with the FDA: “Mozarc Medical US LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.