TissueTech PROKERA Plus corneal bandage recall: Microbial contamination risk
TissueTech recalls non-sterile PROKERA Plus corneal bandages due to potential microbial contamination. Affected lots and serial numbers listed. Consumers should contact TissueTech for details.
Lower-risk recall
Potential exposure of product to microbial contamination.
Contact the company
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. Read more at govinfonow.com/recall/63945-tissuetech-prokera-plus-corneal-bandage-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63945-tissuetech-prokera-plus-corneal-bandage-recall-microbial-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0551-2021
Cite this page
“TissueTech PROKERA Plus corneal bandage recall: Microbial contamination risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63945-tissuetech-prokera-plus-corneal-bandage-recall-microbial-contamination-risk. Based on FDA recall #Z-0551-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2021%22&limit=1).
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
All 3 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 II- Status
Terminated- Distribution
US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0550-2021 | PROKERA, non-sterile - Product Usage: Biologic corneal bandage.; Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PK16-00761,20-PK16-00762,20-PK16-00763,20-PK16-00767,20-PK16-00796,20-PK16-00797,20-PK16-00798,20-PK16-00803,20-PK16-00815,20-PK16-00816,20-PK16-00817,20-PK16-00818,20-PK16-00819,20-PK16-00759,20-PK16-00760,20-PK16-00808,20-PK16-00809,20-PK16-00781,20-PK16-00820,20-PK16-00791,20-PK16-00792,20-PK16-00804,20-PK16-00805,20-PK16-00806,20-PK16-00807,20-PK16-00810,20-PK16-00811,20-PK16-00812,20-PK16-00813,20-PK16-00814,20-PK16-00768,20-PK16-00769,20-PK16-00782,20-PK16-00783,20-PK16-00778,20-PK16-00770,20-PK16-00771,20-PK16-00772,20-PK16-00773,20-PK16-00774,20-PK16-00775,20-PK16-00776,20-PK16-00777,20-PK16-00765,20-PK16-00779,20-PK16-00780,20-PK16-00799,20-PK16-00800,20-PK16-00793,20-PK16-00794,20-PK16-00795,20-PK16-00784,20-PK16-00785,20-PK16-00801,20-PK16-00764,20-PK16-00821,20-PK16-00789,20-PK16-00790,20-PK16-00766,20-PK16-00786,20-PK16-00787,20-PK16-00788, and 20-PK16-00802 | 63 units |
| Z-0551-2021 | PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.; Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKP-00994,20-PKP-00988,20-PKP-00989,20-PKP-00990,20-PKP-00991,20-PKP-00992,20-PKP-00993,20-PKP-00995,20-PKP-00996, and 20-PKP-00997 | 10 units |
| Z-0552-2021 | PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.; Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKS-14212,20-PKS-14213,20-PKS-14214,20-PKS-14215,20-PKS-14216,20-PKS-14217,20-PKS-14218,20-PKS-14219,20-PKS-14202,20-PKS-14203,20-PKS-14204,20-PKS-14205,20-PKS-14191,20-PKS-14192,20-PKS-14193,20-PKS-14194,20-PKS-14195,20-PKS-14196,20-PKS-14197,20-PKS-14198,20-PKS-14199,20-PKS-14200,20-PKS-14207,20-PKS-14208,20-PKS-14209,20-PKS-14210,20-PKS-14211,20-PKS-14206,20-PKS-14188,20-PKS-14189,20-PKS-14190,20-PKS-14201,20-PKS-14304,20-PKS-14272,20-PKS-14273,20-PKS-14274,20-PKS-14275,20-PKS-14276,20-PKS-14277,20-PKS-14290,20-PKS-14291,20-PKS-14292,20-PKS-14293,20-PKS-14294,20-PKS-14278,20-PKS-14279,20-PKS-14280,20-PKS-14297,20-PKS-14307,20-PKS-14308,20-PKS-14298,20-PKS-14309,20-PKS-14310,20-PKS-14311,20-PKS-14312,20-PKS-14313,20-PKS-14281,20-PKS-14282,20-PKS-14283,20-PKS-14284,20-PKS-14285,20-PKS-14286,20-PKS-14287,20-PKS-14288,20-PKS-14289,20-PKS-14305,20-PKS-14306,20-PKS-14295,20-PKS-14296,20-PKS-14314,20-PKS-14299,20-PKS-14300,20-PKS-14301,20-PKS-14302, and 20-PKS-14303 | 75 units |
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.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 24 states.
FDA distribution: “US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-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.