FDA DevicesClass II
THORACIC ROBOTS, DYNJ908777B
Published: April 8, 2026Recall ID: Z-1707-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
THORACIC ROBOTS, DYNJ908777B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98530 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI-DI 10198459269196 (EA) 40198459269197 (CS) LOTS 25EBD732 25GBG733 25IBQ613 25JBD457 25KBT352 26ABA235 26ABP735 |
| Postal code | 60093-2753 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 14,379 kits total |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260216 |
| Center classification date | 20260401 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.