CLASS II ONGOING Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
Haag Streit Surgical Floor stands FS 2-11 recalled
Haag-Streit USA is recalling Haag Streit Surgical Floor stands FS 2-11 (, distributed nationwide in the US. The recall was initiated on 20 Nov 2020 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-0697-2021
- FDA event ID
- 86707
- Recalling firm
- Haag-Streit USA, Mason, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Nov 2020
- FDA classified
- 23 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 20 Nov 2020 | Recall initiated by company | |
| 23 Dec 2020 | Classified by FDA | +33 days |
| 30 Dec 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
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
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
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view
Where it was distributed
US Nationwide distribution in the state of OK.
Questions about this recall
Why was it recalled?
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
Which lots are affected?
Floor stands FS 2-11, FS 2-15 with the software REF 615 588 in versions 2.0 to 3.3. FS 2-11 Ref. # 615H511 Serial Numbers:From 1001; FS 2-15 Ref. #615H515 Serial Numbers From 1001; HS Hi-R NEO 900 Ref. # 657 Serial Numbers 820 from 101; HS Hi-R NEO 900A Ref # 657 821 Serial Numbers from 101 Unique Device Identifier (UDI) HS Hi-R NEO 900 +EMWM657 820 0/$+serial no. HS Hi-R NEO 900A +EMWM657 821 0/$+serial no. FS 2 11 +EMWM 615H5110/$+serial no. FS 2-15 +EMWM 615H515 0/$+serial no.
Where was it sold?
US Nationwide distribution in the state of OK.
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.
More recalls from Haag-Streit USA
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OCT-Camera 211 01 A1, Running recalled by Haag-Streit USA | Haag-Streit USA | Device Malfunction | Nationwide |
| Device | CLASS II | OCT-Camera 211 01 A3 recalled by Haag-Streit USA | Haag-Streit USA | Device Malfunction | Nationwide |
| Device | CLASS II | Eyesuite 9.3.1 software, Lenstar, Model LS900: ac-powered slit-lamp recalled | Haag-Streit USA | Device Malfunction | Nationwide |
| Device | CLASS II | HS Hi-R NEO 900A Reference # recalled by Haag-Streit USA | Haag-Streit USA | Device Malfunction | OH |
| Device | CLASS II | HS Hi-R NEO 900 Reference # recalled by Haag-Streit USA | Haag-Streit USA | Device Malfunction | OH |
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