Z-1709-2026Class II
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-16 / Open, Classified
Medline Industries, LP began a recall of Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1709-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
- Product code
- OGR Ear, Nose, And Throat Surgical Tray
- 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 root cause
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 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.
- Product codes and lots
- 1. DYNJ900898I UDI-DI 10198459273513 (EA) 40198459273514 (CS) LOTS 25DME064 25HMD841 25JMD489 25KME329 25KMH848 25LMC029 25LMH235 25LMK305 DYNJ901922G UDI-DI 10195327640422 (EA) 40195327640423 (CS) LOTS 24KBP812 2. DYKM1417I UDI-DI 10195327456757 (EA) 40195327456758 (CS) LOTS 24DLA405 24ELA912 24GLA871 24ILA151 24JLA326 DYKM1417J UDI-DI 10198459191640 (EA) 40198459191641 (CS) LOTS 25BLA761 25BLA886 25DLA353 25ELA056 25FLA429 25HLA196 25HLA242 25KLA388 25KLA610 3. DYNJ58146A UDI-DI 10193489611977 (EA) 40193489611978 (CS) LOTS 23KDA851 24ADC096 24CDB107 24DDB887 24IDA855 24JDB494 24LDA691 25BMF825 25DMD969 25FMC760 25GMD422 4. DYNDA2138A UDI-DI 10193489874594 (EA) 40193489874595 (CS) 24DBM325 24DBM383 25DBK159
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1705-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1706-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1707-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1708-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1709-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1710-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1711-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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