CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report

products labeled as the following recalled by Leica Microsystems

Leica Microsystems is recalling products labeled as the following: Leica M320 Microscope Systems with Article Numbers, distributed nationwide in the US. The recall was initiated on 4 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesA. 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)

Quantity recalled8,564 Total Units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2555-2018
FDA event ID: 80229
Recalling firm: Leica Microsystems, Buffalo Grove, IL
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2018
FDA classified: 26 Jul 2018
Reported: 1 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

4 Jun 2018	Recall initiated by company
26 Jul 2018	Classified by FDA	+52 days
1 Aug 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended 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.

Where it was distributed

Worldwide Distribution US Nationwide in the states of : CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX. International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE, CHINA, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONGKONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, MALAYSIA, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN,THAILAND, TURKEY, UK

Nationwide California Colorado Connecticut Florida Hawaii Idaho Illinois Kansas Kentucky Louisiana Maryland Michigan Minnesota Missouri North Carolina New Jersey New York Ohio Pennsylvania South Dakota

Questions about this recall

Why was it recalled?

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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