Mallinckrodt Manufacturing LLC
Mallinckrodt Manufacturing LLC appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 4 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2450-2023, Class I) was initiated on August 8, 2023. Its most recent 510(k) clearance was granted on January 3, 2025.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 4
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2450-2023 | Class I | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used | August 8, 2023 |
| Z-2687-2017 | Class II | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Sto | October 17, 2014 |