CellEra recalls Silver calcium Alginate Dressings with incorrect instructions
CellEra recalls 20545 Vitale Silver calcium Alg: 10/box dressings with incorrect instructions. Correct version of instructions will be mailed to affected customers.
Lower-risk recall
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.
Contact the company
What happened, in plain English
CellEra is recalling 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box due to incorrect Instructions for Use (IFU) included in some units. This could lead to improper use if customers follow outdated instructions. Read more at govinfonow.com/recall/61425-cellera-recalls-silver-calcium-alginate-dressings-with-incorrect-instructions.
Source Summary by GovInfoNow · govinfonow.com/recall/61425-cellera-recalls-silver-calcium-alginate-dressings-with-incorrect-instructions · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0804-2022
Cite this page
“CellEra recalls Silver calcium Alginate Dressings with incorrect instructions.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61425-cellera-recalls-silver-calcium-alginate-dressings-with-incorrect-instructions. Based on FDA recall #Z-0804-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2022%22&limit=1).
Why it’s dangerous
The recalled dressings include an incorrect version of the Instructions for Use that goes beyond the cleared 510(k) regulations. This means users might follow instructions that are not approved for the product, potentially leading to improper wound care.
Who’s affected
Patients using these dressings for wound care. Healthcare providers who use the product are most at risk of incorrect application.
How to tell if you have this one
Check for the lot numbers 212299, 00865276008703, or 00856276008697 on the packaging. The product is a 4x5 size, 10-pack box.
- Brand
CellEra- Product
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0801-2022 | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box; Lot 200999 GTIN 10856276008649, 00856276008642, 00856276008635 | 30,000 ea |
| Z-0802-2022 | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box; Lot 229999 GTIN 10856276008762, 00856276008765, 00856276008758 | 9200 ea |
| Z-0803-2022 | 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box; Lot 206999 GTIN 10856276008663, 00856276008666, 00856276008659 | 4400 ea |
| Z-0804-2022 | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box; Lot 212299 GTIN 10856276008700, 00865276008703, 00856276008697 | 17850 ea |
| Z-0805-2022 | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box; Lot 212299, 200999 GTIN 10850005565250, 00850005565253, 00850005565246 | 11770 ea |
What to do — step by step
Check Product Details
Look for the lot numbers 212299, 00865276008703, or 00856276008697 on the packaging.
Contact CellEra
Reach out to CellEra LLC to confirm if your product is affected and get instructions for the correct instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0804-2022 (December 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0804-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.