Reported Dec 16, 2020 · Terminated

PROKERA, non-sterile - Product Usage: Biologic corneal bandage.

TissueTech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: TissueTech, Inc. · 8305 NW 27th St Ste 101 · Doral, FL · 33122-1934

Is this the product you have?

  • PROKERA
  • non-sterile - Product UsageBiologic corneal bandage
Lot codes and dates
  • Lot Codes
    • BTR192864
    • BTR194678
    • BTR192872
  • BTR193024 Serial ID

    63 of 63 codes

    • 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
Amount recalled
63 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Potential exposure of product to microbial contamination.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 6, 2023 · Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.