The Recall Desk

Manufacturer

embecta Medical II LLC

2 recalls in our database name embecta Medical II LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2026-09-23

Of the 2 recalls from embecta Medical II 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.

1–2 of 2

  • HighFDA (Devices)·Z-3179-2026·2026-09-23

    Embecta Medical Recalls Nano Pro Pen Needles Distributed as Commercial Devices

    Embecta Medical II LLC is recalling Nano Pro Un-Cannulated Demo Samples because investigational-use-only pen needles were inadvertently distributed as commercially marketed devices.

    Product
    EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3180-2026·2026-09-23

    Embecta Medical Recalls Pen Needles Labeled for Investigational Use Only

    Embecta Medical II LLC is recalling pen needles labeled 'For Investigational Use Only' that were inadvertently distributed as commercially marketed devices.

    Product
    EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
    Category
    Medical Device
    Distribution
    Distributed nationwide