Recall Z-1710-2026

Medline Industries, LP · initiated February 16, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O 13. XPS, DYNJ907605

Codes / lots: 1. DYKE2091 UDI-DI 10198459606397 (EA) 40198459606398 (CS) LOT 25LBR616 2. DYNJ900898G UDI-DI 10195327479473 (EA) 40195327479474 (CS) LOTS 23JBI824 23KBJ535 24ABR789 24ABV917 24BBU610 24DMK530 24FMF039 24GME122 24JMB670 24KMH657 25AMA403 25BME938 DYNJ901922I UDI-DI 10198459237270 (EA) 40198459237271 (CS) LOTS 25BBL628 25FBM655 25HBW072 25KBO230 3. DYNJ38313B UDI-DI 10884389857700 (EA) 40884389857701 (CS) LOTS 24BBR676 24CBF032 24FBD924 24JBE567 25EBA277 25FBO580 25IBI418 4. DYNJ32750G UDI-DI 10889942212491 (EA) 40889942212492 (CS) LOTS 23KME954 23LMD492 24BMF722 24FMH267 24HMC509 DYNJ32750I UDI-DI 10198459245695 (EA) 40198459245696 (CS) LOTS 25BMA765 25DMC474 25EMI991 25IME718 26AMJ190 5. DYNJ911252 UDI-DI 10198459305030 (EA) 40198459305031 (CS) LOTS 25EBU007 25LBC286 25LBI365 26ABC803 26ABU372 6. DYNJ58146B UDI-DI 10198459478253 (EA) 40198459478254 (CS) LOTS 25HMG837 25JMJ636 26AMJ160 7. DYNJ902016K UDI-DI 10195327391706 (EA) 40195327391707 (CS) LOTS 23JBL313 23KBX206 24ABG361 24ABS317 24CBU624 24DBT777 24EBP517 24IBB815 24LBH029 24LBK316 25BBD830 25BBK993 25DBQ241 25DBR926 DYNJ902016L UDI-DI 10198459452703 (EA) 40198459452704 (CS) LOTS 25HBV912 25IBT298 25KBT137 8. DYNJ908686…

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-1710-2026
Initiated
February 16, 2026
Posted by FDA
April 1, 2026
Product code
LRO – General Surgery Tray
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1705-2026 Class IIAirway Exam Kit, DYKE1796Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… 02/16/2026Open, Classified
Z-1706-2026 Class IIMedline 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-1707-2026 Class IITHORACIC ROBOTS, DYNJ908777BKits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… 02/16/2026Open, Classified
Z-1708-2026 Class IIMedline 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 IIMedline 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-1711-2026 Class IIMEDLINE ANTERIOR HIP PACK DYNJ64672BKits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… 02/16/2026Open, Classified