FDA Medical Device Recalls (openFDA)
Stradis Medical, LLC dba Stradis Healthcare: STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
- Recall number
- Z-0481-2023
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Product
- STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
- Status
- Open, Classified
- Initiated
- 2022-11-02
- Posted
- 2022-12-14
- Terminated
- not on file
- Reason
- Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
- Root cause
- Packaging process control
- Action
- Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
- Quantity
- 80 kits
- Distribution
- US nationwide distribution, and Canada.
- Lot, serial or model codes
- a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 22255491484
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HOZ
- Firm FEI
- 1000111025
- Firm city
- Peachtree Corners
- Firm state
- GA
- 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