Quick Facts at a Glance
- Recall Date
- February 16, 2026
- Hazard Level
- HIGH
- Brands
- Olympus, Medline Industries, LP
- 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
- Olympus, Medline Industries, LP
- Product type
- Biopsy valve kit (single-use)
- Model numbers
- UDI-DI 10198459269196, 40198459269197, LOTS 25EBD732, 25GBG733, 25IBQ613, 25JBD457, 25KBT352, 26ABA235 +1 more
- 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 biopsy valve kits used in thoracic robotic procedures. Consumers rely on sterile, single-use valves to maintain airway safety during procedures.
Why This Is Dangerous
Rubber fragments detaching from the valves can become a foreign body in the airway, potentially requiring removal and causing inflammation or hypoxia.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt use of affected kits, potentially delaying procedures and prompting supplier inquiries.
Practical Guidance
How to identify if yours is affected
- 1. Locate the kit and verify models and lot numbers.
- 2. Compare lot numbers against those listed in recall data.
Where to find product info
UDI, lot numbers, and kit identifiers are printed on the product packaging and accompanying documentation.
What timeline to expect
Refunds/replacements or follow-up actions are being coordinated by the manufacturer; typical timelines vary by facility.
If the manufacturer is unresponsive
- Document all communications with Medline and the hospital
- Escalate to FDA recall contact if needed.
How to prevent similar issues
- Ask about valve components when purchasing kits.
- Maintain an updated list of recalled lots and serial numbers for inventory control.
- Verify supplier recalls before procurement for surgical kits.
Documentation advice
Keep copies of recall notices, correspondences, and inventory batch lists.
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Product Details
Kits: Thoracic Robotic biopsy valve kit DYNJ908777B. UDI-DI 10198459269196 (EA) and 40198459269197 (CS). LOTS: 25EBD732, 25GBG733, 25IBQ613, 25JBD457, 25KBT352, 26ABA235, 26ABP735. Distributor/seller: Medline Industries, LP. Nationwide distribution in the US. States: CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 14,379 kits recalled total
- Follow manufacturer recall instructions
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Safety Guide
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