The Recall Desk

Manufacturer

CellEra LLC

6 recalls in our database name CellEra LLC as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2022-03-23

Of the 6 recalls from CellEra 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.

1–6 of 6

  • ModerateFDA (Devices)·Z-0802-2022·2022-03-23

    Calcium Alginate Wound Dressings Recalled for Incorrect Instructions

    CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.

    Product
    20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0805-2022·2022-03-23

    Calcium Alginate Wound Dressings Recalled for Incorrect Instructions

    CellEra LLC is recalling Vitale Silver calcium alginate dressings nationwide because packages contain incorrect Instructions for Use with language not approved by the FDA. The firm is providing replacement packages with corrected instructions.

    Product
    20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0801-2022·2022-03-23

    Medical dressing recall issued due to incorrect instructions for use

    CellEra LLC recalls Vitale Silver calcium Alginate Dressing Ropes due to incorrect Instructions for Use in product packaging. The manufacturer is replacing affected units with corrected instructions.

    Product
    20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0804-2022·2022-03-23

    Calcium alginate wound dressings recalled for incorrect instruction labeling

    CellEra LLC is recalling Vitale Silver calcium alginate dressings because the included Instructions for Use contain language exceeding FDA clearance. The firm is replacing affected units with correct instructions.

    Product
    20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0803-2022·2022-03-23

    Medical device wound dressing recall for incorrect instructions

    CellEra LLC is recalling Vitale Silver calcium Alginate Dressings because product packages contain incorrect Instructions for Use with language beyond FDA 510(k) clearance scope. The firm is replacing affected units with correct instructions.

    Product
    20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
    Category
    Medical Device
    Distribution
    Distributed nationwide