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Extended Tip Applicator 201108Recalls & reported problems

Integra Lifesciences Corporation · Extended Tip Applicator 8cm single pack · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K091315); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 22, 2025Open, Classified

    Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

    Z-1960-2025 · Root cause: Process change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091315. One submission often covers many models, so check the product and lot details in each record.

  • Z-1959-2025 · May 22, 2025 · Open, Classified
    Extended Tip Applicator, 15 CM, Box of 5.
  • Z-1958-2025 · May 22, 2025 · Open, Classified
    Extended Tip Applicator, 8CM, Box of 5.

Other Syringe, Piston devices

All Syringe, Piston devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.