The Recall Desk

Manufacturer

Mallinckrodt Manufacturing LLC

2 recalls in our database name Mallinckrodt Manufacturing LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2023-09-20

Of the 2 recalls from Mallinckrodt Manufacturing LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • SevereFDA (Devices)·Z-2450-2023·2023-09-20

    Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure

    Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.

    Product
    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2687-2017·2017-07-12

    Mallinckrodt Recalls ArterX Surgical Sealant Due to Improper Labeling

    Mallinckrodt is recalling ArterX Surgical Sealant because improper labeling led to improper storage. The affected units were distributed to the UK.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states