Z-1708-2026Class II

Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915

Name: Z-1708-2026 Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Creator: Medline Industries, LP
Published: 2026-02-16
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-16 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915 on 2026-02-16. 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 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1708-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-16
Posted: 2026-04-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Product code: OFF Central Venous Catheter 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. UDI-DI 10195327501259 (EA) 40195327501250 (CS) LOTS 24DBW065 24EBV301 24HBB492 24JBW143 25ABG413 25CBH359 25DBD213 25GBP569 25HBQ088 25KBF725 26ABE643 2. UDI-DI 10195327371029 (EA) 40195327371020 (CS) LOTS 24FBM018 24GBL319

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1708-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1705-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1706-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1707-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1708-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1709-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1710-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1711-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01

Product code OFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)