Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Microspecialties with 4 device recalls and 2 warning letters. The most recent is a warning letter dated Oct 8, 2026: Warning letter: Medical Devices.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 8, 2026 | Warning letter: Medical DevicesCDRH | Warning letters |
| May 8, 2025 | Warning letter: Sterility assurance, Process validation, Method validationCDRH | Warning letters |
| Jun 5, 2024 | Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:Class II · Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound inf | Device recalls |
| Jun 5, 2024 | Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061Class II · Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound inf | Device recalls |
| Jun 5, 2024 | Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069WClass II · Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound inf | Device recalls |
| Jun 5, 2024 | Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060Class II · Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound inf | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
