Quick Facts at a Glance
- Recall Date
- May 4, 2026
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Geographic Scope
- 1 states
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
- Medline Industries, LP
- Model numbers
- Medline Kit Number/SKU BIOB686: UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618, Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23BBK690, Lot Number 23ABK356, Lot Number 23ABG037 +4 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 4, 2026
Reported by FDA DEVICE
June 24, 2026
RecallRadar source check
June 30, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Full Description
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products). Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.. Classification: Class II. Quantity: 123030 units. Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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