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, INFANTS
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
- Sterile Pack/Header Bag
- Model numbers
- 1646381
- 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
The CPT BASIC IR PACK is a sterile surgical or infection-control kit component used by healthcare providers during procedures.
Why This Is Dangerous
A compromised header seal may allow contamination, leading to possible infection or ineffective sterility.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Healthcare facilities may need to quarantine affected lots and reroute procedures to ensure sterility standards are met.
Practical Guidance
How to identify if yours is affected
- Verify Model Number 1646381 on the device label.
- Confirm Lot Number 1646381.
- Confirm Florida distribution if needed.
Where to find product info
Inspect the packaging label for Model 1646381, UDI 10809160363256, and Lot 1646381.
What timeline to expect
AVID Medical will provide recall instructions and next steps; timelines are not specified here.
If the manufacturer is unresponsive
- Consult your healthcare provider for interim guidance.
- Contact AVID Medical for escalation instructions.
How to prevent similar issues
- Verify sterility indicators on all sterile packs before use.
- Use only packs from trusted distributors with verifiable sterility documentation.
Documentation advice
Keep all recall notices, packing labels, and supplier communications. Document lot numbers and UDI for each unit.
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Product Details
Brand: AVID Medical. Product: CPT BASIC IR PACK. Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Quantity: 228 units. Distribution: US nationwide with Florida. Recall date: 2025-08-04. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Florida distribution mentioned
- Recall date August 4, 2025
- Active status as of September 17, 2025
- Notification via email
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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