Recall Z-1707-2026
Medline Industries, LP · initiated February 16, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
THORACIC ROBOTS, DYNJ908777B
Codes / lots: UDI-DI 10198459269196 (EA) 40198459269197 (CS) LOTS 25EBD732 25GBG733 25IBQ613 25JBD457 25KBT352 26ABA235 26ABP735
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.
FDA-determined cause: Under Investigation by firm
Action taken
Firm notified customers on 2/16/26. Consignees were provided with a copy of Olympus's notification, which includes reminders to follow the IFU. According to the firm, the component can continue to be utilized by the customer, along with the remainder of the kit.
Details
- Recall number
- Z-1707-2026
- Initiated
- February 16, 2026
- Posted by FDA
- April 1, 2026
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 14,379 kits total
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1705-2026 Class II | Airway Exam Kit, DYKE1796Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… | 02/16/2026Open, Classified |
| Z-1706-2026 Class II | Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2.…Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… | 02/16/2026Open, Classified |
| Z-1708-2026 Class II | Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT…Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… | 02/16/2026Open, Classified |
| Z-1709-2026 Class II | Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G…Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… | 02/16/2026Open, Classified |
| Z-1710-2026 Class II | Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2.…Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… | 02/16/2026Open, Classified |
| Z-1711-2026 Class II | MEDLINE ANTERIOR HIP PACK DYNJ64672BKits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… | 02/16/2026Open, Classified |