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SurgiMendRecalls & reported problems across all models

Tei Biosciences Inc. · 75 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

7 open recalls name at least one SurgiMend model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
7

We found 75 models of SurgiMend by Tei Biosciences Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

7 FDA recall records name at least one of these models by its device identifier, 7 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SurgiMend recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2075-2023 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗

  2. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2074-2023 · Root cause: Under Investigation by firm · names 13 of these models · Recall details · FDA record ↗

  3. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2073-2023 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗

  4. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2072-2023 · Root cause: Under Investigation by firm · names 10 of these models · Recall details · FDA record ↗

  5. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2071-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

  6. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2070-2023 · Root cause: Under Investigation by firm · names 13 of these models · Recall details · FDA record ↗

  7. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2069-2023 · Root cause: Under Investigation by firm · names 21 of these models · Recall details · FDA record ↗

SurgiMend models

75 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Tei Biosciences Inc. products

All Tei Biosciences Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page