CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

Medline convenience kits containing Olympus biopsy valves recalled

Medline Industries is recalling Medline convenience kits containing Olympus biopsy valves: Bronch Pack, DYKE2096 Non MB, distributed nationwide in the US. The recall was initiated on 16 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. UDI-DI 10198459629334 (EA) 40198459629335 (CS) LOTS 26AMG895 2. UDI-DI 10198459545283 (EA) 40198459545284 (CS) LOTS 25LBJ366 26ABR365 3. UDI-DI 10195327471859 (EA) 40195327471850 (CS) LOTS 24EBA317 24EBV431 24IBD694 24JBQ783
Quantity recalled14,379 kits total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1706-2026
FDA event ID
98530
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
16 Feb 2026
FDA classified
1 Apr 2026
Reported
8 Apr 2026
Type
Voluntary: Firm initiated
Reason category
Foreign Material

Timeline

16 Feb 2026Recall initiated by company
1 Apr 2026Classified by FDA+44 days
8 Apr 2026Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A

Where it was distributed

US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.

Nationwide CaliforniaFloridaIllinoisIndianaKentuckyMassachusettsMarylandMontanaNew YorkOhioPennsylvaniaTennesseeTexas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

1. UDI-DI 10198459629334 (EA) 40198459629335 (CS) LOTS 26AMG895 2. UDI-DI 10198459545283 (EA) 40198459545284 (CS) LOTS 25LBJ366 26ABR365 3. UDI-DI 10195327471859 (EA) 40195327471850 (CS) LOTS 24EBA317 24EBV431 24IBD694 24JBQ783

Where was it sold?

US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 98530

This product is part of a recall event; the main page for the event is Thoracic Robots, Dynj908777b recalled by Medline Industries.

ReportedClassRecallCompanyReasonWhere
CLASS IIThoracic Robots, Dynj908777b recalled by Medline IndustriesMedline IndustriesForeign MaterialNationwide
CLASS IIAirway Exam Kit, DYKE1796 recalled by Medline IndustriesMedline IndustriesForeign MaterialNationwide
CLASS IIMedline kits containing Olympus biopsy valves: Bronchoscopy recalledMedline IndustriesForeign MaterialNationwide
CLASS IIMedline kits containing Olympus biopsy valves recalledMedline IndustriesForeign MaterialNationwide
CLASS IIMedline kits containing Olympus biopsy valves: BAL KIT recalledMedline IndustriesForeign MaterialNationwide
CLASS IIMedline Anterior Hip Pack Dynj64672b recalled by Medline IndustriesMedline IndustriesForeign MaterialNationwide

More recalls from Medline Industries

All 709
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIRollator, Bariatric, Basic Steel, Burgundy recalledMedline IndustriesForeign MaterialNationwide
DeviceCLASS IIRollator, Bariatric, Basic Steel, Blue recalled by Medline IndustriesMedline IndustriesForeign MaterialNationwide
DeviceCLASS IMedline Basic Homecare Beds and Medlite Homecare Beds recalledMedline IndustriesDevice MalfunctionNationwide
DeviceCLASS IMedline Basic Homecare Beds and Medlite Homecare Beds recalledMedline IndustriesOtherNationwide
DeviceCLASS IIMedline Convenience Kits: Major Pack recalled by Medline IndustriesMedline IndustriesOtherNationwide

Other Other Medical Devices recalls

All 13,908
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIPlastics Tray kits recalled by Avid MedicalAvid MedicalForeign MaterialNationwide
DeviceCLASS IIHeart Prep Tray kits recalled by Avid MedicalAvid MedicalOtherNationwide
DeviceCLASS IIPack Open Heart Cfh kits recalled by Avid MedicalAvid MedicalOtherNationwide
DeviceCLASS IISperm Ab Elisa (96 well plate test) recalled by DRG InternationalDRG InternationalOtherNationwide
DeviceCLASS IIIBeneView Series recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide