FDA Medical devices recall ·
Medline kits containing Olympus biopsy valves: 1… recall
- Recall number
- Z-1710-2026
- Date
- (initiated February 16, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14,379 kits total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 1019532
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
States: California Florida Illinois Indiana Kentucky Massachusetts Maryland Montana New York Ohio Pennsylvania Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1710-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.