Extended Tip ApplicatorRecalls & reported problems across all models

We found 3 models of Extended Tip Applicator by Integra Lifesciences Corporation in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

3 FDA recall records name at least one of these models by its device identifier, 3 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

Extended Tip Applicator 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 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 · Recall details · FDA record ↗

2. May 22, 2025Open, Classified

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

   Z-1959-2025 · Root cause: Process change control · Recall details · FDA record ↗

3. May 22, 2025Open, Classified

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

   Z-1958-2025 · Root cause: Process change control · Recall details · FDA record ↗

Extended Tip Applicator models

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

• Extended Tip Applicator 205108

  Syringe, Piston
  1 recall0 reports
• Extended Tip Applicator 205115

  Syringe, Piston
  1 recall0 reports
• Extended Tip Applicator 201108

  Syringe, Piston
  1 recall0 reports

Other Integra Lifesciences Corporation products

• MAYFIELD32 models · 1,082 reports
• AURORA Surgiscope4 models · 3 reports · 2 recalls
• Hermetic3 models · 63 reports
• Omni-Tract447 models · 7 reports · 1 recall
• CAMINO6 models · 32 reports
• DuraSeal3 models · 25 reports
• AccuDrain3 models · 23 reports