Alcon or Endure Ophthalmic Microscope Product Usage: Used for low… — Class II medical device recall Z-0961-2019
Terminated recall by Alcon Research Laboratories Ltd., reported 2019-03-06, distributed nationwide. Potential for the optical head to detach from the stand due to the lack of thread adhesive.
| Recall number | Z-0961-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research Laboratories Ltd., Fort Worth, TX, United States |
| Recall initiated | 2018-07-17 |
| Classified | 2019-02-26 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BS, CA, CL, CO, CZ, DE, DK, DO, EC, ES, FI, GB, GT, ID, IN, IT, JM, JP, KE, LB, LK, MX, NO, PE, PH, PL, RO, SE, SK, SV, TH, TW, UA, VN |
| Reason classes | device malfunction |
| Serial numbers | 001, 002, 003, 101200157, 1401148001X, 1401148101X, 1401148103X, 1401148104X, 1401148105X, 1401148201X, 1401148202X, 1401148203X, 1401148204X, 1401554509X, 1401554603X, 1401554606X, 1401554608X, 1401554610X, 1401579101X, 1401579103X, 1401831601X, 1401845004X, 1401845005X, 1401954603X, 1401974102X and 452 more |
Product
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Reason for recall
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Machine access
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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.