Reported Jan 18, 2023 · Ongoing

Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

Integra LifeSciences Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650

Is this the product you have?

    • Codman Surgical Patties
    • Part number 801400
    • SURG PATXRAY 1/2X1/2-200
    • Lot 6396457
Lot codes and dates
  • UDI-DI 10381780514961 Lot Number6396457 Expiration date 06/30/2027
Amount recalled
168 US; 3 OUS

Where it was sold

Why it was recalled

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.