CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
Leica Microsystems Proveo 8, Part Number 10449058, surgical recalled
Leica Microsystems is recalling Leica Microsystems Proveo 8, Part Number 10449058, surgical, distributed nationwide in the US. The recall was initiated on 21 Nov 2022 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-0475-2023
- FDA event ID
- 91200
- Recalling firm
- Leica Microsystems, deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Nov 2022
- FDA classified
- 9 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 21 Nov 2022 | Recall initiated by company | |
| 9 Dec 2022 | Classified by FDA | +18 days |
| 21 Dec 2022 | 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
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
Product as listed by the FDA
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
Which lots are affected?
Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001. ***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.
Where was it sold?
US Nationwide
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.
Other products in this recall event
2 other products · FDA event 91200This product is part of a recall event; the main page for the event is M530 OHX recalled by Leica Microsystems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | M530 OHX recalled by Leica Microsystems | Leica Microsystems | Other | Nationwide | |
| CLASS II | Provido, Part Numbers 10448950 (Premium), 10448976 (Standard) recalled | Leica Microsystems | Other | Nationwide |
More recalls from Leica Microsystems
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Provido, Part Numbers 10448950 (Premium), 10448976 (Standard) recalled | Leica Microsystems | Other | Nationwide |
| Device | CLASS II | M530 OHX recalled by Leica Microsystems | Leica Microsystems | Other | Nationwide |
| Device | CLASS II | Leica Surgical Operating Microscopes, PROvido Part Numbers recalled | Leica Microsystems | Labeling Errors | Nationwide |
| Device | CLASS II | Leica Surgical Operating Microscopes, Arveo recalled | Leica Microsystems | Labeling Errors | Nationwide |
| Device | CLASS II | Leica Surgical Operating Microscopes, ARveo recalled | Leica Microsystems | Labeling Errors | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |