Quick Facts at a Glance
- Recall Date
- February 16, 2026
- Hazard Level
- HIGH
- Brands
- Medline Industries, Olympus
- 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
- Medline Industries, Olympus
- Product type
- Biopsy valve kit (single-use) containing Olympus biopsy valves
- Model numbers
- UDI-DI 10198459629334 (EA) 40198459629335 (CS) LOTS 26AMG895, UDI-DI 10198459545283 (EA) 40198459545284 (CS) LOTS 25LBJ366 26ABR365, UDI-DI 10195327471859 (EA) 40195327471850 (CS) LOTS 24EBA317 24EBV431 24IBD694 24JBQ783
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 16, 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
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
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
About This Product
These are convenience kits that include Olympus biopsy valves used during endoscopic procedures. The valves are single-use components within the kit.
Why This Is Dangerous
Detachment of rubber fragments from the valve slit could create a foreign body in the patient’s airway during procedures, potentially requiring removal and causing inflammation or hypoxia.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The immediate impact is a halt to using the affected kits in clinical settings and potential procedural delays or additional interventions to remove detached fragments.
Practical Guidance
How to identify if yours is affected
- Review UDI-DI and LOT numbers on the valve components per the recall documentation
- Consult your facility’s procurement records to identify affected lots
Where to find product info
Recall notices and manufacturer communications contain the full identification details including UDIs and lot numbers
What timeline to expect
Replacement or refunds will be processed according to Medline’s recall plan, typically within weeks to a few months
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a formal consumer complaint with FDA/related bodies if applicable
How to prevent similar issues
- Verify device components against recall lists before use
- Maintain updated recalls with your biomedical engineering team
- When purchasing, request confirmatory documentation on device recall status
Documentation advice
Document recall notices, lot numbers, UDI numbers, and all communications with Medline or healthcare providers; retain records for the risk management file
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Product Details
- Kits: BRONCH PACK, DYKE2096; NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182; PULMONARY BRONCH PACK, DYNDA2861A - Units recalled: 14,379 kits total - UDI-DI/LOTS: See model list below - Where sold: United States, nationwide distribution to hospitals and clinics in CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX - When sold: prior to recall date (recall effective 2026-02-16) - Price: Not disclosed
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Kits contain Olympus biopsy valves
- Rubber fragment detachment reported in valve slit
- Nationwide US distribution in CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX
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Safety Guide
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