CLASS II ONGOING Device recall · Reported 8 Jan 2025 · FDA Enforcement Report
Ivalon Cellulose Surgical Spear- Intended To Be Used During recalled
Carwild is recalling Ivalon Cellulose Surgical Spear- Intended To Be Used During Ophthalmic Surgical, distributed in Alabama, Florida, Illinois, Pennsylvania, South Carolina. The recall was initiated on 22 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0799-2025
- FDA event ID
- 95909
- Recalling firm
- Carwild, New London, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Oct 2024
- FDA classified
- 2 Jan 2025
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 22 Oct 2024 | Recall initiated by company | |
| 2 Jan 2025 | Classified by FDA | +72 days |
| 8 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Where it was distributed
IL, FL, SC. PA, AL Foreign: Netherlands
Questions about this recall
Why was it recalled?
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Which lots are affected?
LOT NUMBER: 24G1739
Where was it sold?
IL, FL, SC. PA, AL Foreign: Netherlands
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95909| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ivalon Eye Wick- Intended to be used for the removal recalled by Carwild | Carwild | Sterility | 5 states | |
| CLASS II | Ivalon Anatomical Nasal Packing with Airway Tube recalled by Carwild | Carwild | Sterility | 5 states |
More recalls from Carwild
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ivalon Anatomical Nasal Packing with Airway Tube recalled by Carwild | Carwild | Sterility | 5 states |
| Device | CLASS II | Ivalon Eye Wick- Intended to be used for the removal recalled by Carwild | Carwild | Sterility | 5 states |
| Device | CLASS II | Fabco Ors Dental Rolls, 1-1/2" Sterile recalled by Carwild | Carwild | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |