Z-1705-2026Class II

Airway Exam Kit, DYKE1796

Name: Z-1705-2026 Airway Exam Kit, DYKE1796
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 Airway Exam Kit, DYKE1796 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-1705-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-16
Posted: 2026-04-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Airway Exam Kit, DYKE1796
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
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: UDI-DI 10193489874716 (ea) 40193489874717 (case) Lots 24CBT023 24FBB701 24LBL343 25GBP141

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1705-2026
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 CAI

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)