Reported Jul 2, 2014 · Terminated

ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems

The Anspach Effort, Inc.

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: The Anspach Effort, Inc. · 4500 Riverside Drive · Palm Beach Gardens, FL · 33410-4235

Is this the product you have?

  • ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Lot codes and dates
  • Part Number
    • SP-3013-00
    • SP-3013-01
    • SP-3013-02
    • SP-3013-03
  • Serial Numbers
    • 200042
    • 200044
    • 200014
    • 200056
    • 200064
    • 200055
    • 200044
    • 200038
    • 200013
    • 310009
    • 310007
    • 20043
    • 200145
    • 200144
Amount recalled
113

This recall covers 45 products

The agency filed one notice per product. You are reading one of them; the other 44 are below.

32 more are in the archive.

Where it was sold

Why it was recalled

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

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

Notice updated Aug 7, 2014 · Data as of Sep 19, 6:06 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.