CLASS II Device recall · Reported 15 Aug 2018 · FDA Enforcement Report
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac recalled
Leica Microsystems is recalling Leica M530 OHX Microscope System Supplied with 100 - 120 Vac, distributed in 22 states. The recall was initiated on 25 Jun 2018 and the FDA has classified it as Class II.
Check your package
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-2659-2018
- FDA event ID
- 80497
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2018
- FDA classified
- 7 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Jun 2018 | Recall initiated by company | |
| 7 Aug 2018 | Classified by FDA | +43 days |
| 15 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recall is due to a design weakness of the power insert module.
Product as listed by the FDA
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Where it was distributed
United States distribution: AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NY, NV, OH, OR, PA, TX, UT, PR. International distribution to Japan, Brazil, Columbia, Ecuador, Mexico, Taiwan
ArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaIllinoisIndianaKansasKentuckyLouisianaMissouriNew JerseyNevadaNew YorkOhioOregonPennsylvaniaPuerto Rico
Questions about this recall
Why was it recalled?
Recall is due to a design weakness of the power insert module.
Which lots are affected?
US: 90116001, 30118001, 51215001, 201117001, 30916001, 270216001, 100917001, 31117001, 00817001, 0316001, 31217001, 180118001, 200218001, 151217001, 21217001, 21214001, 80218001, 170118001, 01017002, 101017001, 170915001, 150117001, 150217001, 291117001, 260517001, 300915001, 0318001, 30318001, 100915001, 310717001, 140716001, 50516001, 281116001, 300517001, 0316001, 30115001, 200617001, 190117001, 170117001, 241217001, 261217001, 271217001, 90118001, 0617001, 250118001, 280115001, 191015001, 81117001, 150617001, 120417001, 140917001, 10318001, 140417001, 250717001, 80518001, 160616001, 170417001, 150417001, 11116001, 91017001, 81117002, 281117001, 20218001, 300118001, 131015001, 140318001, 110516001, 00318001, 160118001, 30518001, 200316001, 120917001, 210118001, 310717001, 30218001, 1217001, 190617001, 130617001, 280817001, 80317001, 310817001, 10917001, 60317001, 60218001, 80917001 230318001, 170318001; Puerto Rico: 241216001, 261216001; JAPAN: 140717001,171017001, 211117001, 291217001, 290118001, 210218001, 280218001, 020318001, 120318001, 160318001; BRAZIL: 120416001, 220917001, 311017001, 70118001, 70318001; COLOMBIA: 60517001; ECUADOR: 170316001, 231216001, 190917001; MEXICO: 31215001, 130117001, 91217001; TAIWAN: 190815001, 220317001, 190317001, 40517001, 210717001, 210717002, 211217001
Where was it sold?
United States distribution: AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NY, NV, OH, OR, PA, TX, UT, PR. International distribution to Japan, Brazil, Columbia, Ecuador, Mexico, Taiwan
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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