Quick Facts at a Glance
- Recall Date
- February 11, 2026
- Hazard Level
- HIGH
- Brand
- Burlington Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Breast Axilla and Thyroid Coverage Device
- Model numbers
- BATB, BATH
- Sold at
- Unknown
- 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
BAT Coverage is a radiation attenuation device designed to protect the breast, axilla, and thyroid areas during procedures.
Why This Is Dangerous
Attenuation material may degrade over time, potentially reducing shielding effectiveness and shortening device lifespan.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Affects 1,489 units worldwide with potential reduced protection during radiologic exams; users should stop use and await replacement or refund guidance.
Practical Guidance
How to identify if yours is affected
- Check model numbers BATB or BATH.
- Review UDI-DI codes listed in the recall (00197513011941 with BAT variants; 00197513011934 with BATH variants).
- Verify manufacture dates 2025-01-16 to 2026-01-21 and Xenolite 800 attenuation material.
Where to find product info
On device labeling, packaging and the UDI printed on the product; FDA recall page linked above.
What timeline to expect
No specific timeline given; recall processes typically take 4-8 weeks after processing.
If the manufacturer is unresponsive
- Escalate to consumer protection agencies
- File a report with the FDA recall enforcement page
- Consult your healthcare provider for interim options
How to prevent similar issues
- Verify recalls before purchase and during procurement
- Ask for documentation on attenuation materials and shielding durability
- Keep up-to-date with regulatory recalls for medical devices
Documentation advice
Keep recall letter, purchase records, model numbers, UDI codes, and all correspondence with the manufacturer
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Product Details
Model Numbers: BATB and BATH. UDI-DI: 00197513011941 (BATC18-R8BATB-2XF, BATC18-R8BATB-3XF); 00197513011941 (BATC8-R8BATB-LF, BATC8-R8BATB-LM, BATC8-R8BATB-MF, BATC8-R8BATB-MM, BATC8-R8BATB-PLUS, BATC8-R8BATB-SF, BATC8-R8BATB-XLF, BATC8-R8BATB-XLM, BATC8-R8BATB-XSF). Model Number: BATH. UDI-DI: 00197513011934 (BATC18-R8BATH-2XF, BATC18-R8BATH-2XM, BATC18-R8BATH-3XF, BATC18-R8BATH-3XM); 00197513011934 (BATC8-R8BATH-LF, BATC8-R8BATH-LM, BATC8-R8BATH-MF, BATC8-R8BATH-MM). Distribution: Worldwide, including nationwide in the US and Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, at
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US nationwide and listed countries
- Model BATB and BATH with multiple UDI-DI variants
- Xenolite 800 attenuation material in device
- Recall date 2026-02-11; status ACTIVE
- Hazard: attenuation degradation over time
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