FDA Medical Device Recalls (openFDA)
MICROspecialties, Inc.: Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
- Recall number
- Z-2336-2024
- Recalling firm
- MICROspecialties, Inc.
- Product
- Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
- Status
- Open, Classified
- Initiated
- 2024-06-05
- Posted
- 2024-07-11
- Terminated
- not on file
- Reason
- Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- MICROspecialties issued Voluntary recall for Synergetics Eye Trays letter on 6/3/24 to the Distributor Synergetics. Letter states reason for recall, health risk and action to take: Review: Inventory for affected product codes Communicate with customers impacted by this notice. Segregate and Quarantine all affected product. Utilize return instructions below Disseminate this notice to any customers who may have been affected. Return the below acknowledgement form by Fax to:860-788-2030 Or email to: quality@microspecialties.com Contact quality@.microspecialties.com for product return instructions. Please return by 6/25/24. For additional information regarding this please contact quality@.microspecialties.com.
- Quantity
- 804 units
- Distribution
- MO
- Lot, serial or model codes
- UDI: 10841305101132 LOT: P62764970R
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- Firm FEI
- 3002616700
- Firm city
- Middletown
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28