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Recall Observatory FDA recall evidence

Device product

FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048

Z-0922-2026

November 13, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98066
Status
Ongoing
Classification
Class II
Quantity
53 units
Official record key
device-enforcement:Z-0922-2026

Official wording

Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

Code information: DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290

Distribution pattern: US Nationwide distribution in the states CA, CO, IL, KS, and MI.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    weak packaging
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of sterility