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fda_recall · device_recall · high

Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBN…

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:38Z
Source ID
Z-2113-2026
Payload hash
4e7c85c03fbb76525e14fa44

Summary

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL)… Status: Ongoing.

Frequently asked questions

Has Medline Industries, LP had other FDA enforcement actions?
Yes. Argus HQ has recorded 293 total FDA actions tied to Medline Industries, LP: 0 warning letters, 293 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-05-13; Argus observed and indexed it on 2026-07-09.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Medline Industries, LP — Class II recall: Medline Convenience Kits:  1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBN…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medline-industries-lp-z-2113-2026
MLA
"Medline Industries, LP — Class II recall: Medline Convenience Kits:  1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBN…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-medline-industries-lp-z-2113-2026.
Chicago
Argus HQ Research. "Medline Industries, LP — Class II recall: Medline Convenience Kits:  1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBN…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-medline-industries-lp-z-2113-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medline_industries_lp_z_2113_2026_2026,
  title = {Medline Industries, LP — Class II recall: Medline Convenience Kits:  1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBN…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medline-industries-lp-z-2113-2026},
  note = {Accessed: August 27, 2026}
}

Informational only. Not legal, financial, or medical advice.