Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

20545 Vitale Silver calcium Alginate Dressings 4x5 Recalled by CellEra LLC Due to Firm discovered that an incorrect version of the...

Date: December 15, 2021
Company: CellEra LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CellEra LLC directly.

Affected Products

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

Quantity: 17850 ea

Why Was This Recalled?

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CellEra LLC

CellEra LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report