Mallinckrodt Manufacturing, LLC
Mallinckrodt Manufacturing, LLC holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2025, with 2 FDA device recalls on record.
Top product codes for Mallinckrodt Manufacturing, LLC
FDA recalls by Mallinckrodt Manufacturing, LLC
- Z-2450-2023 — Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
- Z-2687-2017 — Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mallinckrodt Manufacturing, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.