TissueTech PROKERA Plus corneal bandage recall: Microbial contamination risk

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Recalling firmTissueTech, Inc.8305 NW 27th St Ste 101, N/A · Doral, FL 33122-1934

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

TissueTech is recalling non-sterile PROKERA Plus corneal bandages because they may have microbial contamination. This could lead to infections if used improperly. The recall affects specific lot numbers and serial IDs.

Why it’s dangerous

The non-sterile bandages may be exposed to microbes during manufacturing or storage. If used without proper sterilization, this could cause eye infections.

Who’s affected

People who use PROKERA Plus corneal bandages for eye injuries or surgeries. Those with specific lot codes or serial numbers listed are most at risk.

How to tell if you have this one

Check the lot codes (BTR192864, BTR194678, etc.) and serial IDs (20-PKP-00994 to 20-PKP-00997) on the packaging. These identifiers are listed in the recall notice.

Brand
TissueTech
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot codes (BTR192864, BTR194678, etc.) and serial IDs (20-PKP-00994 to 20-PKP-00997) on the packaging.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states potential microbial contamination, so it is not safe to use without checking the lot and serial numbers.

How do I know if my product is affected?

Check the lot codes (BTR192864, BTR194678, etc.) and serial IDs (20-PKP-00994 to 20-PKP-00997) on the packaging.

What should I do if I have the affected product?

Contact TissueTech directly for instructions on what to do with the product.

Take action

Contact TissueTech

We’ve drafted a message you can send TissueTech to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0551-2021 — TissueTech TissueTech

Hello,

I own a TissueTech that is covered by recall Z-0551-2021 from TissueTech.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0551-2021 (November 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0551-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

TissueTech, Inc. recalls PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.

Lower-risk recall