CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report

Leica ARveo and M530 OH6 microscope systems recalled

Leica Microsystems is recalling Leica ARveo and M530 OH6 microscope systems, distributed nationwide in the US. The recall was initiated on 20 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesM530 OH6 Serial Numbers for Model # 10448680 OH6-016215, OH6-042317, OH6-032016, OH6-009815,OH6-044518 and OH6-030016. Arveo Serial Numbers for Model # 10448999 OHA-006318, OHA-010719, OHA-011919, OHA-000818, OHA-009119, OHA-000718, OHA-014919, OHA-016619, OHA-015919, OHA-007818, OHA-013519, OHA-001218, OHA-012219, OHA-017319, OHA-000418, OHA-017119, OHA-013719, OHA-009919, OHA-017219, OHA-017419, OHA-002218, OHA-000318, OHA-014819, OHA-015219, OHA-003718, OHA-001018, OHA-016019, OHA-012919, OHA-012619, OHA-011719, OHA-012119, OHA-010819, OHA-016119, OHA-009219, OHA-002618, OHA-015719, OHA-012019, OHA-009519, OHA-000618, OHA-008518, OHA-004818, OHA-012719, OHA-010619, OHA-001118, OHA-010419, OHA-016319, OHA-016519, OHA-010219, OHA-012519, OHA-015419, OHA-009018, OHA-016419, OHA-016719, OHA-008918, OHA-007618, OHA-009619, OHA-012319, OHA-010519, OHA-005418.

Quantity recalledDomestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.

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-2399-2020
FDA event ID: 85722
Recalling firm: Leica Microsystems, Buffalo Grove, IL
Classification: Class II
Status: Terminated
Recall initiated: 20 May 2020
FDA classified: 17 Jun 2020
Reported: 24 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 May 2020	Recall initiated by company
17 Jun 2020	Classified by FDA	+28 days
24 Jun 2020	Published in enforcement report	+7 days

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

Reason for recall

Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.

Product as listed by the FDA

Leica ARveo and M530 OH6 microscope systems.

Where it was distributed

Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan

Nationwide Alabama Arkansas Arizona California Connecticut District of Columbia Delaware Florida Illinois Kentucky Louisiana Michigan Minnesota Missouri North Carolina New York Ohio Tennessee Texas Utah

Questions about this recall

Is Leica ARveo and M530 OH6 microscope systems recalled?

Yes. Leica Microsystems recalled Leica ARveo and M530 OH6 microscope systems on 20 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2399-2020.

Why was it recalled?

Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.

Which lots are affected?

M530 OH6 Serial Numbers for Model # 10448680 OH6-016215, OH6-042317, OH6-032016, OH6-009815,OH6-044518 and OH6-030016. Arveo Serial Numbers for Model # 10448999 OHA-006318, OHA-010719, OHA-011919, OHA-000818, OHA-009119, OHA-000718, OHA-014919, OHA-016619, OHA-015919, OHA-007818, OHA-013519, OHA-001218, OHA-012219, OHA-017319, OHA-000418, OHA-017119, OHA-013719, OHA-009919, OHA-017219, OHA-017419, OHA-002218, OHA-000318, OHA-014819, OHA-015219, OHA-003718, OHA-001018, OHA-016019, OHA-012919, OHA-012619, OHA-011719, OHA-012119, OHA-010819, OHA-016119, OHA-009219, OHA-002618, OHA-015719, OHA-012019, OHA-009519, OHA-000618, OHA-008518, OHA-004818, OHA-012719, OHA-010619, OHA-001118, OHA-010419, OHA-016319, OHA-016519, OHA-010219, OHA-012519, OHA-015419, OHA-009018, OHA-016419, OHA-016719, OHA-008918, OHA-007618, OHA-009619, OHA-012319, OHA-010519, OHA-005418.

Where was it sold?

Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan

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

More recalls from Leica Microsystems

All 40

Reported	Class	Recall	Company	Reason	Where
21 Dec 2022Device	CLASS II	Leica Microsystems Proveo 8, Part Number 10449058, surgical recalled	Leica Microsystems	Other	Nationwide
21 Dec 2022Device	CLASS II	Provido, Part Numbers 10448950 (Premium), 10448976 (Standard) recalled	Leica Microsystems	Other	Nationwide
21 Dec 2022Device	CLASS II	M530 OHX recalled by Leica Microsystems	Leica Microsystems	Other	Nationwide
5 Oct 2022Device	CLASS II	Leica Surgical Operating Microscopes, PROvido Part Numbers recalled	Leica Microsystems	Labeling Errors	Nationwide
5 Oct 2022Device	CLASS II	Leica Surgical Operating Microscopes, Arveo recalled	Leica Microsystems	Labeling Errors	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide