Haag-Streit recalls surgical floor stands FS 2-11 and FS 2-15 with specific software versions that may cause eye injury during use in ophthalmology. Affected units have serial numbers starting from 1001.
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
“Haag-Streit Surgical Floor Stands with Software Error Risk Patient Eye Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63831-haag-streit-surgical-floor-stands-with-software-error-risk-patient. Based on FDA recall #Z-0697-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2021%22&limit=1).
Haag-Streit USA Inc recalled Haag Streit Surgical Floor stands FS 2-11 and FS 2-15 used with specific operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released, posing a risk to patients' eyes. The Food and Drug Administration announced the Class II recall on November 20, 2020.
How to tell if you have it
Haag-Streit FS 2-11 (Ref no. 615H511), Serial Numbers from 1001
Haag-Streit FS 2-15 (Ref no. 615H515), Serial Numbers from 1001
HS Hi-R NEO 900 (Ref no. 657 820), Serial Numbers from 101
HS Hi-R NEO 900A (Ref no. 657 821), Serial Numbers from 101
Software REF 615 588 versions 2.0 to 3.3
The hazard
The software error in REF 615 588 versions 2.0 to 3.3 may cause the focusing movement to not stop when releasing the footswitch button, resulting in a potential risk to the patient's eye.
Context
GovInfoNow's records show Haag-Streit USA Inc has issued three other recalls since July 31, 2019, including a November 3, 2021 recall for OCT-Camera 211 01 A1 software due to laser safety risks and an April 15, 2021 recall for Eyesuite 9.3.1 software regarding patient data mix-up risks. Other recent recalls of similar products include a November 7, 2025 Da Vinci Surgical System recall for software errors causing instrument failure, a February 23, 2026 Stryker CHROMOPHARE Softlit Ring Surgical Light recall for ceiling support risks, and an November 12, 2025 Howmedica Stryker CranialMask Tracker recall for software errors preventing device use.
How to tell if you have this one
Check if your Haag-Streit surgical floor stand has serial numbers starting from 1001. The affected models are FS 2-11 (Ref 615H511) and FS 2-15 (Ref 615H515) with software versions 2.0 to 3.3. Also check the unique device identifier codes on the product.
Brand
Haag-Streit
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Haag-Streit surgical floor stand. If it is 2.0 to 3.3, it is affected.
Contact Manufacturer
Reach out to Haag-Streit USA Inc for guidance on next steps and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0697-2021 (November 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0697-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.