CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
Thoracic Robots, Dynj908777b recalled by Medline Industries
Medline Industries is recalling Thoracic Robots, Dynj908777b, 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
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-1707-2026
- 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
- Device type
- Other Medical Devices
Timeline
| 16 Feb 2026 | Recall initiated by company | |
| 1 Apr 2026 | Classified by FDA | +44 days |
| 8 Apr 2026 | Published 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
THORACIC ROBOTS, DYNJ908777B
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?
UDI-DI 10198459269196 (EA) 40198459269197 (CS) LOTS 25EBD732 25GBG733 25IBQ613 25JBD457 25KBT352 26ABA235 26ABP735
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Airway Exam Kit, DYKE1796 recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide | |
| CLASS II | Medline kits containing Olympus biopsy valves: Bronchoscopy recalled | Medline Industries | Foreign Material | Nationwide | |
| CLASS II | Medline kits containing Olympus biopsy valves recalled | Medline Industries | Foreign Material | Nationwide | |
| CLASS II | Medline convenience kits containing Olympus biopsy valves recalled | Medline Industries | Foreign Material | Nationwide | |
| CLASS II | Medline kits containing Olympus biopsy valves: BAL KIT recalled | Medline Industries | Foreign Material | Nationwide | |
| CLASS II | Medline Anterior Hip Pack Dynj64672b recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
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