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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96934

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 22, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Integra LifeSciences Corp. (NeuroSciences)

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Extended Tip Applicator, 8CM, Box of 5.

Z-1958-2025
Recall number
Z-1958-2025
Initiated
May 22, 2025
Classification
Class I
Status
Ongoing
Quantity
6,216 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification
Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.

device · product 2 of 3

Extended Tip Applicator, 15 CM, Box of 5.

Z-1959-2025
Recall number
Z-1959-2025
Initiated
May 22, 2025
Classification
Class I
Status
Ongoing
Quantity
2,524 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification
Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model/Catalog Number: 205115; UDI: 10381780000150; All Lots.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.

device · product 3 of 3

Extended Tip Applicator 8CM, Box of 1.

Z-1960-2025
Recall number
Z-1960-2025
Initiated
May 22, 2025
Classification
Class I
Status
Ongoing
Quantity
212 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification
Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model/Catalog Number: 201108; UDI 10381780000167; All Lots.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.

Field note

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