The Recall Desk
HighFDA (Devices)·Z-0551-2021·Announced 2020-12-16

TissueTech Recalls PROKERA Plus Corneal Bandages Due to Microbial Contamination Risk

TissueTech, Inc. is recalling 10 units of PROKERA Plus non-sterile biologic corneal bandages due to potential exposure to microbial contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the hazard is microbial contamination, which fits the High severity criteria.

Plain-English summary

TissueTech, Inc. is recalling 10 units of PROKERA Plus, non-sterile biologic corneal bandages. The recall is being conducted because of a potential exposure of the product to microbial contamination.

The affected units were distributed nationwide in the United States, 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. The specific lot codes involved are BTR192864, BTR194678, BTR192872, and BTR193024. The serial IDs for the recalled units are 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.

Consumers and healthcare providers should check their inventory for these specific lot and serial numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with the recall instructions.

The recalled product

Product
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Manufacturer
TissueTech, Inc.
Category
Medical Device — Ophthalmic
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 3 recalled by TissueTech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · TissueTech, Inc.

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Same hazard · microbial contamination

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