Reported Dec 16, 2020 · Terminated

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

    75 of 75 codes

    • 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
Amount recalled
75 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, 4:54 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.