Reported Aug 1, 2018 · Terminated

Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419,…

Leica Microsystems, 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: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622

Is this the product you have?

  • Leica Microsystems
  • products labeled as the followingLeica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486
  • Product UsageIntended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations
Lot codes and dates
  • A. Article Number 10448419 (Serial Numbers 160714001, 10814001, 200814001, 200814002, 90914001, 021014001, 21214001, 31214001, 81214001, 190115001, 190115002); B Article Number 10448420 (Serial Numbers 180514001, 180514002, 190514001, 190514002, 190514003, 190514004, 200514001, 200514002, 200514003, 200514004, 210514001, 210514002, 210514003, 210514004, 220514001, 220514002, 220514003, 260514001, 260514002, 270514001, 270514002, 270514003, 270514004, 270514005, 280514001, 280514002, 280514003, 290514001, 300514001, 300514002, 300514003, 20614001, 40614001, 50614001, 50614002, 50614003, 60614001, 90614001, 90614002, 100614001, 100614002, 100614003, 120614001, 120614002, 120614003, 130614001, 130614002, 130614003, 130614004, 90514002, 160614001, 160614002, 160614003, 160614004, 170614001, 190614001, 200614001, 200614002, 200614003, 230614001, 230614002, 230614003, 240614001, 250614001, 250614002, 250614003, 250614004, 250614005, 270614001, 300614001, 300614002, 300614003, 10714001, 10714002, 10714003, 10714004, 20714001, 20714002, 20714003, 30714001, 30714002, 40714001, 40714002, 40714003, 70714001, 70714002, 70714003, 80714001, 80714002, 80714003, 90714001, 100714001, 110714001, 140714001, 160714001, 160714002, 170714001, 170714002, 180714001, 180714002, 180714003, 210714001, 210714002, 210714003, 220714001, 220714002, 220714003, 220714004, 230714001, 250714001, 250714002, 250714003, 250714004, 250714005, 250714006, 290714001, 290714002, 290714003, 290714004, 300714001, 300714002, 300714003, 300714004, 310714001, 310714002, 310714003, 310714004, 10814001, 10814002, 040814001, 040814002, 040814003, 040814004, 050814001, 050814002, 050814003, 050814004, 060814001, 060814002, 070814001, 070814002, 070814003, 070814004, 080814001, 080814002, 120814001, 120814002, 130814001, 130814002, 130814003, 130814004, 140814001, 140814002, 140814003, 140814004, 150814001, 150814002, 150814003, 160814001, 160814002, 160814003, 180814001, 180814002, 180814003, 190814001, 190814002, 190814003, 190814004, 190814005, 190814006, 200814001, 200814002, 210814001, 210814002, 210814003, 210814004, 220814001, 220814002, 220814003, 250814001, 250814002, 270814001, 270814002, 270814003, 270814004, 270814005, 270814006, 280814001, 280814002, 280814003, 280814004, 290814001, 290814002, 10914001, 10914002, 10914003, 10914004, 20914001, 20914002, 30914001, 30914002, 30914003, 80714002, 70814003, 40914001, 40914002, 50914001, 50914002, 80914001, 80914002, 80914003, 80914004, 80914005, 90914001, 90914002, 90914003, 100914001, 100914002, 100914003, 100914004, 110914001, 110914002, 110914003, 120914001, 120914002, 120914003, 120914004, 120914005, 130914001, 130914002, 130914003, 150914001, 160914001, 160914002, 160914003, 160914004, 160914005, 170914001, 170914002, 170914003, 170914004, 170914005, 180914001, 180914002, 180914003, 180914004, 180914005, 190914001, 190914002, 190914003, 200914001, 200914002, 200914003, 200914004, 200914005, 220914001, 220914002, 220914003, 220914004, 230914001, 230914002, 90614001, 90614002, 240914001, 240914002, 240914003, 250914001, 250914002, 100614002, 100614003, 260914001, 260914002, 260914003, 260914004, 290914001, 290914002, 290914003, 300914001, 300914002, 300914003, 021014001, 021014002, 031014001, 031014002, 031014003, 031014004, 41014001, 41014002, 41014003, 41014004, 41014005, 41014006, 41014007, 61014001, 61014002, 71014001, 71014002, 71014003, 71014004, 81014001, 81014002, 81014003, 81014004, 81014005, 91014001, 91014002, 101014001, 101014002, 101014003, 101014004, 121014001, 121014002, 121014003, 121014004, 121014005, 121014006, 131014001, 141014001, 141014002, 141014003, 141014004, 151014001, 151014002, 151014003, 151014004, 161014001, 161014002, 161014003, 171014001, 171014002, 171014003, 171014004, 181014001, 181014002, 181014003, 181014004, 191014001, 191014002, 191014003, 191014004, 201014001, 201014002, 201014003, 211014001, 211014002, 211014003, 211014004, 231014001, 231014002, 231014003, 241014001, 241014002, 241014003, 241014004, 241014005, 281014001, 281014002, 281014003, 281014004, 281014005, 291014001, 291014002, 291014003, 291014004, 291014005, 291014006, 301014001, 301014002, 311014001, 311014002, 311014003, 311014004, 11114001, 11114002, 11114003, 11114004, 11114005, 31114001, 31114002, 31114003, 31114004, 31114005, 41114001, 41114002, 41114003, 51114001, 51114002, 51114003, 51114004, 81114001, 81114002, 81114003, 81114004, 101114001, 101114002, 101114003, 111114001, 111114002, 121114001, 121114002, 121114003, 121114004, 131114001, 131114002, 141114001, 141114002, 141114003, 161114001, 161114002, 161114003, 161114004, 161114005, 161114006, 171114001, 171114002, 171114003, 171114004, 181114001, 181114002, 181114003, 191114001, 191114002, 191114003, 201114001, 201114002, 201114003, 201114004, 201114005, 211114001, 211114002, 211114003, 211114004, 241114001, 241114002, 241114003, 241114004, 251114001, 251114002, 251114003, 251114004, 261114001, 261114002, 261114003, 261114004, 271114001, 271114002, 281114001, 281114002, 11214001, 11214002, 21214001, 31214001, 31214002, 31214003, 41214001, 41214002, 41214003, 51214001, 51214002, 71214001, 71214002, 81214001, 81214002, 81214003, 91214001, 91214002, 91214003, 91214004, 101214001, 101214002, 101214003, 111214001, 111214002, 111214003, 121214001, 121214002, 121214003, 121214004, 151214001, 151214002, 151214003, 151214004, 151214005, 151214006, 151214007, 151214008, 161214001, 161214002, 171214001, 171214002, 171214003, 181214001, 181214002, 181214003, 181214004, 191214001, 191214002, 191214003, 191214004, 191214005, 191214006, 211214001, 221214001, 221214002, 241214001, 241214002, 241214003, 261214001, 261214002, 261214003, 261214004, 271214001, 271214002, 271214003, 281214001, 281214002, 281214003, 20115001, 20115002, 20115003, 20115004, 50115001, 50115002, 60115001, 60115002, 60115003, 60115004, 60115005, 60115006, 70115001, 70115002, 80115001, 80115002, 90115001, 90115002, 90115003, 90115004, 110115001, 110115002, 120115002, 120115003, 120115004, 130115001, 130115002, 130115003, 130115004, 140115001, 140115002, 140115003, 140115004, 150115001, 150115002, 160115001, 160115002, 190115001, 190115002, 200115001, 200115002, 200115003, 200115004, 210115002, 210115004, 130215004, 110515005, 120115004, 130115003, 50915001); C. Article Number 10448485 (Serial Numbers 180514001, 180514002, 230514001, 230514002, 230514003, 230514004, 260514001, 260514002, 280514001, 290514001, 20614001, 20614002, 20614003, 30614001, 30614002, 40614001, 40614002, 60614001, 60614002, 90614001, 90614002, 110614001, 110614002, 170614001, 170614002, 170614003, 170614004, 170614005, 180614001, 190614001, 190614002, 190614003, 190614004, 190614005, 200614001, 230614001, 300614001, 20714001, 30714001, 30714002, 40714001, 80714001, 90714001, 90714002, 100714001, 100714002, 110714001, 110714002, 140714001, 140714001, 170714001, 180714001, 210714001, 080814001, 080814002, 120814001, 120814002, 150814001, 220814001, 260814001, 260814002, 260814003, 260814004, 290814001, 290814002, 20914001, 20914002, 50914001, 50914002, 110914001, 130914001, 150914001, 150914002, 230914001, 240914001, 250914001, 250914002, 290914001, 300914001, 011014001, 011014002, 011014003, 011014004, 021014001, 41014001, 61014001, 91014001, 91014002, 101014001, 121014001, 151014001, 211014001, 231014001, 241014001, 241014002, 301014001, 301014002, 301014003, 311014001, 11114001, 11114002, 11114003, 41114001, 81114001, 101114001, 111114001, 111114002, 191114001, 211114001, 271114001, 271114002, 281114001, 11214001, 21214001, 21214002, 51214001, 71214001, 71214002, 71214003, 101214001, 111214001, 161214001, 161214002, 171214001, 191214001, 191214002, 221214001, 221214002, 231214001, 231214002, 231214003, 241214001, 251214001, 251214002, 251214003, 70115001, 80115001, 80115002, 150115001, 150115002, 160115001, 160115002); D. Article Number 10448486 (Serial Numbers 110614001, 110614002, 120614001, 310114001, 060814001, 060814002, 160814001, 61014001, 121014001, 281014001, 131114001, 131114002, 181114001, 231214001)
Amount recalled
8,564 Total Units

Where it was sold

Why it was recalled

Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Leica Microsystems, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 25, 2021 · Data as of Sep 19, 5:29 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.