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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmFebruary 16, 2026
Date PostedApril 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1710-2026
Recall Event ID 98530
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductMedline 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
Code Information 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 UDI-DI 10195327145330 (EA) 40195327145331 (CS) LOT 23LBG479 9. DYKE1859 UDI-DI 10195327171469 (EA) 40195327171460 (CS) LOTS 23LBU165 24ABT730 24CBL345 24FBK106 24HBJ512 25DBS024 25EBL346 10. DYNJ901666L UDI-DI 10193489986815 (EA) 40193489986816 (CS) LOTS 24DDC241 24EDB399 11. DYNJ908777A UDI-DI 10195327415174 (EA) 40195327415175 (CS) LOTS 23JBV709 23KBC057 23LBP026 23LBP071 23LBP286 24BBH036 24DBD851 24FBC615 24GBH920 24HBS270 24KBL822 25ABE547 25BBP040 25BBR359 25CBA577 12. DYNJ900482N UDI-DI 10195327509941 (EA) 40195327509942 (CS) LOTS 23KDB600 24ADA178 DYNJ900482O UDI-DI 10195327596569 (EA) 40195327596560 (CS) LOTS 24CDA456 24EDC051 24GDB830 24IDB049 24JDB140 24KDA731 25ADB869 25BDA267 25CMD906 13. DYNJ907605 UDI-DI 10193489468052 (EA) 40193489468053 (CS) LOTS 23JBA743 23JBI519 23LBQ647 24ABX014 24BBQ594
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer 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 2		Under Investigation by firm
ActionFirm 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.
Quantity in Commerce14,379 kits total
DistributionUS Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LRO
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