FDA Recalls high

Medline Kits Recall Involving Olympus Biopsy Valves

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medline Industries, LP is recalling 14,379 kits containing Olympus biopsy valves due to potential rubber fragment detachment, which could lead to health risks.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 15, 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 recalled Olympus biopsy valves. The issue involves an increase in complaints about rubber fragment detachment, which could result in a foreign body in the patient's tracheobronchial tree, potentially requiring intervention, along with risks of inflammatory response, hypoxia, and prolonged procedures.

Which Products Are Affected

The affected products are various Medline kits, totaling 14,379 units, 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 kits include:

  1. BRONCH PROCEDURE KIT, DYKE2091 with UDI-DI 10198459606397 (EA) and 40198459606398 (CS), Lot 25LBR616
  2. BRONCHSCOPY, DYNJ900898G with UDI-DI 10195327479473 (EA) and 40195327479474 (CS), Lots 23JBI824, 23KBJ535, 24ABR789, 24ABV917, 24BBU610, 24DMK530, 24FMF039, 24GME122, 24JMB670, 24KMH657, 25AMA403, 25BME938; and DYNJ901922I with UDI-DI 10198459237270 (EA) and 40198459237271 (CS), Lots 25BBL628, 25FBM655, 25HBW072, 25KBO230
  3. BRONCHSCOPY PACK, DYNJ38313B with UDI-DI 10884389857700 (EA) and 40884389857701 (CS), Lots 24BBR676, 24CBF032, 24FBD924, 24JBE567, 25EBA277, 25FBO580, 25IBI418
  4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G with UDI-DI 10889942212491 (EA) and 40889942212492 (CS), Lots 23KME954, 23LMD492, 24BMF722, 24FMH267, 24HMC509; and DYNJ32750I with UDI-DI 10198459245695 (EA) and 40198459245696 (CS), Lots 25BMA765, 25DMC474, 25EMI991, 25IME718, 26AMJ190
  5. KIT, WR THORACIC, DYNJ911252 with UDI-DI 10198459305030 (EA) and 40198459305031 (CS), Lots 25EBU007, 25LBC286, 25LBI365, 26ABC803, 26ABU372
  6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B with UDI-DI 10198459478253 (EA) and 40198459478254 (CS), Lots 25HMG837, 25JMJ636, 26AMJ160
  7. LEX THORACIC, DYNJ902016K with UDI-DI 10195327391706 (EA) and 40195327391707 (CS), Lots 23JBL313, 23KBX206, 24ABG361, 24ABS317, 24CBU624, 24DBT777, 24EBP517, 24IBB815, 24LBH029, 24LBK316, 25BBD830, 25BBK993, 25DBQ241, 25DBR926; and DYNJ902016L with UDI-DI 10198459452703 (EA) and 40198459452704 (CS), Lots 25HBV912, 25IBT298, 25KBT137
  8. ORGAN PROCUREMENT, DYNJ908686 with UDI-DI 10195327145330 (EA) and 40195327145331 (CS), Lot 23LBG479
  9. PULMONARY PACK, DYKE1859 with UDI-DI 10195327171469 (EA) and 40195327171460 (CS), Lots 23LBU165, 24ABT730, 24CBL345, 24FBK106, 24HBJ512, 25DBS024, 25EBL346
  10. THORACIC, DYNJ901666L with UDI-DI 10193489986815 (EA) and 40193489986816 (CS), Lots 24DDC241, 24EDB399
  11. THORACIC ROBOTICS, DYNJ908777A with UDI-DI 10195327415174 (EA) and 40195327415175 (CS), Lots 23JBV709, 23KBC057, 23LBP026, 23LBP071, 23LBP286, 24BBH036, 24DBD851, 24FBC615, 24GBH920, 24HBS270, 24KBL822, 25ABE547, 25BBP040, 25BBR359, 25CBA577
  12. THORACOTOMY/THORACOSCOPY, DYNJ900482N with UDI-DI 10195327509941 (EA) and 40195327509942 (CS), Lots 23KDB600, 24ADA178; and DYNJ900482O with UDI-DI 10195327596569 (EA) and 40195327596560 (CS), Lots 24CDA456, 24EDC051, 24GDB830, 24IDB049, 24JDB140, 24KDA731, 25ADB869, 25BDA267, 25CMD906
  13. XPS, DYNJ907605 with UDI-DI 10193489468052 (EA) and 40193489468053 (CS), Lots 23JBA743, 23JBI519, 23LBQ647, 24ABX014, 24BBQ594. The recall number is Z-1710-2026.

What You Should Do

As this is a voluntary firm-initiated recall, consumers and users should contact the recalling firm, Medline Industries, LP, for instructions on how to proceed. No specific contact information is provided in the recall details.

Why This Matters

This recall affects medical devices used in procedures, potentially leading to serious health risks like hypoxia, which could require medical intervention and impact patient safety. It highlights the importance of ensuring the integrity of components in medical kits to prevent procedural complications.

Source

This recall information is attributed to the FDA, recall number Z-1710-2026. For more details, visit the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about? ▾
Medline Industries, LP is recalling 14,379 kits containing Olympus biopsy valves due to potential rubber fragment detachment, which could lead to health risks.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert? ▾
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected? ▾
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

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