Quick Facts at a Glance
- Recall Date
- August 4, 2025
- Hazard Level
- HIGH
- Brand
- AVID Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- AVID Medical
- Product type
- Convenience kit
- Model numbers
- Model Number: JACK421-04, UDI: 10809160462973, Lot Number: 1647218
- Colors
- Unknown
- Sizes
- Unknown
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 4, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for open header bag seals, compromising sterility.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AVID Medical, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
This is an ENT procedure convenience kit used by healthcare providers. It is intended for sterile use.
Why This Is Dangerous
Open header bag seals can compromise sterility, increasing infection risk when used in procedures in which sterility is required.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Immediate stop-use is required. No injuries reported yet, but sterility loss poses significant infection risk.
Practical Guidance
How to identify if yours is affected
- Check model JACK421-04.
- Check Lot Number 1647218.
- Confirm distribution in Florida and nationwide.
Where to find product info
Recall notices and FDA enforcement report Z-2530-2025 provide identifiers.
What timeline to expect
Remedy process to be announced by AVID Medical; refunds or replacements likely within weeks to months.
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to FDA CDRH if no response
- Seek alternative suppliers if necessary
How to prevent similar issues
- Verify sterile packaging before use in any sterile kit
- Request supplier certifications and sterile chain documentation
- Maintain updated recall notifications for medical devices
Documentation advice
Keep copy of recall notice, purchase records, batch/UDI, and correspondence with AVID Medical
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Product Details
Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218. Distribution: US Nationwide, in Florida. Quantity: 57 units. Brand: AVID Medical.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Florida distribution within US
- Class II recall
- Recall date 2025-08-04; report date 2025-09-17
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Safety Guide
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