FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medline Anterior Hip Pack recalled for Olympus biopsy valve rubber fragments

OTHERNationwide distribution

Stop using Medline Anterior Hip Pack DYNJ64672B

Medline's Anterior Hip Pack surgical kits contain Olympus biopsy valves that may shed rubber fragments. These fragments could lodge in a patient's airway during a procedure, potentially requiring removal and causing breathing problems or inflammation.

  • Stop using Medline Anterior Hip Pack DYNJ64672B (Lot 23LMD300) immediately
  • Check your facility's inventory for affected kits using UDI-DI 10195327377496 or 40195327377497
  • Contact Medline Industries or the FDA for instructions on returning or destroying unused kits
  • Review patient records if kits were already used and report any airway complications to your healthcare provider
Hazard

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.

Sold states
US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
Affected count
14,379 kits total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE ANTERIOR HIP PACK DYNJ64672B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1711-2026

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