FDA Medical Device Recalls (openFDA)
Carwild Corporation: Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
- Recall number
- Z-0799-2025
- Recalling firm
- Carwild Corporation
- Product
- Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
- Status
- Open, Classified
- Initiated
- 2024-10-22
- Posted
- 2025-01-02
- Terminated
- not on file
- Reason
- Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Root cause
- Equipment maintenance
- Action
- Carwild Corp issued letter On Behalf Of First Aid Bandage Company (Fabco) Recall Notice Urgent via email 12/22/24. Letter states reason for recall, health risk and action to take; Cease Further Distribution Or Use Of Any Remaining Product Immediately . Distributors are responsible to notify all your customers who may have received this product. Please provide shipment history. Call for questions or additional information: Regulatory 1-860-442-4914 x111 Customer Service 1-860-442-4914 x110 .
- Quantity
- 300 units
- Distribution
- IL, FL, SC. PA, AL Foreign: Netherlands
- Lot, serial or model codes
- LOT NUMBER: 24G1739
- 510(k) numbers
- ["K971832"]
- PMA numbers
- not on file
- Product code
- HOZ
- Firm FEI
- 1219313
- Firm city
- New London
- 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