CLASS II Device recall · Reported 27 Apr 2016 · FDA Enforcement Report
(Schweiz) Ag recalled by Leica Microsystems
Leica Microsystems is recalling (Schweiz) Ag. The common name of the device is surgical microscope, distributed nationwide in the US. The recall was initiated on 11 Jan 2016 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-1499-2016
- FDA event ID
- 73557
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2016
- FDA classified
- 15 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 11 Jan 2016 | Recall initiated by company | |
| 15 Apr 2016 | Classified by FDA | +95 days |
| 27 Apr 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
Product as listed by the FDA
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
Where it was distributed
Worldwide Distribution-US (nationwide) including Puerto Rico and the states of MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Great Britain, Italy, Norway, Portugal, Spain, Sweden, Switzerland, India, Japan, Argentina, Chile, Colombia, Mexico, Peru, Belarus, Egypt, Greece, Morocco, Poland, Qatar, Romania, Russian Fed., Saudi Arabia, South Africa, Turkey, Canada, , Australia, Malaysia and Taiwan.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth Carolina
Questions about this recall
Why was it recalled?
An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
Which lots are affected?
OH5-51313; OH4-112214; OH5-49112; OH5-67914; OH4-101213; OH5-20238; OH4-91913; OH5-43312; OH5-54113; OH5-64514; OH4-103014; OH4-106514; OH4-87112; OH4-95413; OH4-94213; OH4-106014; OH4-105514; OH4-94813; OH4-102514; OH4-91113; OH4-87312; OH4-106714; OH5-62113; OH5-46112; OH5-50512; OH4-85912; OH4-81512; OH5-61013; OH5-53913; OH4-95013; OH4-91413; OH4-110614; OH4-94613; OH4-104714; OH4-87212; OH4-85712; OH5-50212; OH4-96213; OH4-88913; OH4-89613; OH5-55113; OH4-99413; OH5-48112; OH4-90713; OH5-66314; OH5-68314; OH4-109414; OH4-83912; OH5-48012; OH4-101313; OH4-86812; OH5-60113; OH5-60313; OH5-37311; OH4-86612; OH5-62913; OH4-95813; OH4-90613; OH4-103614; OH5-48212; OH5-48312; OH5-58313; OH5-53513; OH5-63313; OH4-92613; OH5-43812; OH5-56713; OH5-68114; OH4-81412; OH4-98013; OH5-33911; OH5-61913; OH5-52813; OH4-110714; OH5-46312; OH5-51113; OH4-106814; OH4-112714; OH5-63514; OH5-39012; OH5-63013; OH4-111614; OH4-97013; OH4-97613; OH4-107414; OH4-109514; OH4-109614; OH4-92513; OH4-104614; OH4-93113; OH4-85812; OH4-105414; OH4-99913; OH4-91813; OH4-94913; OH4-107914; OH4-83812; OH4-100413; OH4-107214; OH5-41012; OH5-56013; OH4-85612; OH4-99713; OH4-97513; OH5-50312; OH4-109814; OH5-52013; OH5-61413; OH5-61513; OH5-62613; OH5-68614; OH5-51413; OH4-83112; OH4-108114; OH5-68214; OH4-96513; OH5-51513; OH4-100613; OH4-88213; OH5-58813; OH4-91613; OH5-53713; OH5-53813; OH4-98513; OH4-97713; OH5-36411; OH4-106414; OH5-63213; OH5-63413; OH4-100313; OH4-105914; OH5-67214; OH4-81612; OH4-108314; OH5-46612; OH5-46512; OH5-51913; OH4-96713; OH4-103314; OH4-83212; OH4-87012; OH4-95513; OH4-95713;OH5-35611; OH4-86512; OH4-104314; OH4-104414; OH4-110814; OH4-92413; OH4-100013; OH5-54913; OH5-56213; OH4-102414; OH5-39512; OH5-43712; OH4-98713; OH4-98813; OH4-98913; OH5-43912; OH5-39812; OH5-49012; OH5-39112; OH5-48712; OH5-50813; OH5-35811; OH5-55713; OH4-92713; OH5-58213; OH5-50713; OH4-102214; OH4-112614; OH4-96913; OH4-85512; OH4-92213; OH4-100513; OH4-101113; OH4-20446; OH4-20977; OH4-21557; OH4-22207; OH4-22378; OH4-24019; OH4-69311; OH4-70811; OH4-71411; OH143+684-74711; OH4-76212; OH4-76612; OH4-79312; OH4-79912; OH4-81312; OH4-82512; OH4-99213; OH5-20218; OH5-20328; OH5-20558; OH5-20788; OH5-20808; OH5-20818; OH5-20828; OH5-20858; OH5-21108; OH5-21128; OH5-21379; OH5-21679; OH5-22410; OH5-24410; OH5-20618
Where was it sold?
Worldwide Distribution-US (nationwide) including Puerto Rico and the states of MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Great Britain, Italy, Norway, Portugal, Spain, Sweden, Switzerland, India, Japan, Argentina, Chile, Colombia, Mexico, Peru, Belarus, Egypt, Greece, Morocco, Poland, Qatar, Romania, Russian Fed., Saudi Arabia, South Africa, Turkey, Canada, , Australia, Malaysia and 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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