Quick Facts at a Glance
- Recall Date
- February 11, 2026
- Hazard Level
- HIGH
- Brand
- Burlington Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Burlington Medical
- Product type
- Radiation Attenuation Vest
- Model numbers
- C8PVEST, C8VEST, VESTC18-C8PVEST-2XM, VESTC8-C8PVEST-LF, VESTC8-C8PVEST-LM, VESTC8-C8PVEST-MF, VESTC8-C8PVEST-MM, VESTC8-C8PVEST-SF +13 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 11, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for attenuation degradation over time, decreasing the lifespan.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Burlington Medical, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The product is a protective vest used to shield patients and healthcare workers from radiation exposure during imaging procedures. It relies on attenuation material to reduce exposure.
Why This Is Dangerous
Attenuation degradation over time can reduce the vest's shielding effectiveness and lifespan, potentially increasing radiation exposure risk during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
15,438 units distributed worldwide may have reduced protective value. Consumers should stop using affected vests to avoid diminished shielding during imaging.
Practical Guidance
How to identify if yours is affected
- 1. Locate your Burlington Medical vest and check the model number (C8PVEST or C8VEST and variants).
- 2. Confirm Xenolite 800 attenuation material and manufacture dates between 01/16/2025 and 01/21/2026.
- 3. Stop using the vest immediately.
- 4. Follow recall instructions from Burlington Medical or your healthcare provider.
- 5. Refer to the recall notice for refund or replacement options.
Where to find product info
Recall notices and identifying information are on the FDA enforcement page for Z-1754-2026 and Burlington Medical communications.
What timeline to expect
The recall notice does not specify a refund or replacement timeline.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- File a consumer complaint with the FDA if the company is unresponsive.
How to prevent similar issues
- Ask for documentation about materials and lifespan before purchasing protective vests.
- Verify current shielding materials and expected lifespan with suppliers.
- Keep records of recall notices and serial numbers for future reference.
Documentation advice
Keep recall notices, model numbers, and correspondence as records.
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Product Details
Quantity recalled: 15,438 units. Worldwide distribution with US nationwide and international distribution to Canada, Australia, Bangladesh, and other countries. Manufactured with Xenolite 800 attenuation material between 01/16/2025 and 01/21/2026. Model numbers include C8PVEST and C8VEST with multiple variants (see UDI codes). UDI-DI numbers include 00840331297652 and 00840331297645 for select variants.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution; US nationwide and international distributors
- Manufacture window: 01/16/2025 to 01/21/2026
- Models: C8PVEST, C8VEST and variants (multiple UDI codes)
- Material: Xenolite 800 attenuation material
- Status: ACTIVE as of 2026-04-08
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