FDA Recall of Medline Kits Containing Olympus Biopsy Valves
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Medline Industries is recalling 14,379 kits due to potential detachment of rubber fragments in included Olympus biopsy valves, which could lead to health risks for patients.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 16, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline Industries, LP is recalling certain kits because they contain Olympus biopsy valves that may have rubber fragments detach, potentially causing a foreign body in the patient's tracheobronchial tree, which may require intervention, along with possible inflammatory response, hypoxia, and prolonged procedures.
Which Products Are Affected
The affected products are: 1. BAL KIT, DYNDA2137B and 2. ENDO KIT, DYKE1915. A total of 14,379 kits are involved. The kits were distributed nationwide in the United States, specifically in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, and TX. The recall includes the following code information: For BAL KIT, DYNDA2137B - UDI-DI 10195327501259 (EA), 40195327501250 (CS), and lots 24DBW065, 24EBV301, 24HBB492, 24JBW143, 25ABG413, 25CBH359, 25DBD213, 25GBP569, 25HBQ088, 25KBF725, 26ABE643; For ENDO KIT, DYKE1915 - UDI-DI 10195327371029 (EA), 40195327371020 (CS), and lots 24FBM018, 24GBL319. The official recall number is Z-1708-2026.
What You Should Do
Consumers should contact the recalling firm, Medline Industries, LP, for instructions regarding the recalled kits, as this is a voluntary firm-initiated recall.
Why This Matters
This recall affects medical devices used in procedures, potentially leading to serious health risks for patients, and involves a significant number of kits distributed across multiple states.
Source
Attribution: FDA Recall Number Z-1708-2026. For more information, visit the FDA website.
Original source: FDA Official Notice ↗
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