iDesign — Class II medical device recall Z-0443-2022
Ongoing recall by AMO Manufacturing USA, LLC, reported 2022-01-05, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when th
| Recall number | Z-0443-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMO Manufacturing USA, LLC, Milpitas, CA, United States |
| Recall initiated | 2021-10-21 |
| Classified | 2021-12-29 |
| Reported by FDA | 2022-01-05 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DO, DZ, EC, EG, ES, FR, GB, GR, HK, HR, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MX, MY, NL, NO, NP, OM, PH, PL, PT, SA, SG, SI, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 711 |
| Model numbers | G300, G301 |
Product
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
Reason for recall
Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0443-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.