The Recall Desk

Manufacturer

Arrowhead DE LLC

1 recall in our database name Arrowhead DE LLC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2026-08-26

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

1–1 of 1

  • HighFDA (Devices)·Z-2958-2026·2026-08-26

    Arrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns

    Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.

    Product
    Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixat
    Category
    Medical Device
    Distribution
    Distributed nationwide