Has Medela Inc had other FDA enforcement actions?

This is the only FDA action Argus HQ has on file for Medela Inc as of 2026-07-14. Argus ingests new FDA enforcement records daily.

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 2026-07-08; Argus observed and indexed it on 2026-07-14.

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.

.hq

fda_recall · device_recall · high

Medela Inc — Class II recall: Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Ca…

Name: FDA Recall Record — Medela Inc
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:21Z
Source ID: Z-2645-2026
Payload hash: 64dbcbac90e0308a9f822605…

Summary

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication. Status: Ongoing.

Entities

Medela Inc

View source record ↗

Frequently asked questions

Has Medela Inc had other FDA enforcement actions?: This is the only FDA action Argus HQ has on file for Medela Inc as of 2026-07-14. Argus ingests new FDA enforcement records daily.
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 2026-07-08; Argus observed and indexed it on 2026-07-14.
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). Medela Inc — Class II recall: Brand Name: Medela  Product Name: ENFit ExSet Strl 60  2.0ml PV 1ct EN  Model/Ca…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-medela-inc-z-2645-2026

MLA

"Medela Inc — Class II recall: Brand Name: Medela  Product Name: ENFit ExSet Strl 60  2.0ml PV 1ct EN  Model/Ca…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-medela-inc-z-2645-2026.

Chicago

Argus HQ Research. "Medela Inc — Class II recall: Brand Name: Medela  Product Name: ENFit ExSet Strl 60  2.0ml PV 1ct EN  Model/Ca…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-medela-inc-z-2645-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medela_inc_z_2645_2026_2026,
  title = {Medela Inc — Class II recall: Brand Name: Medela  Product Name: ENFit ExSet Strl 60  2.0ml PV 1ct EN  Model/Ca…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-medela-inc-z-2645-2026},
  note = {Accessed: July 14, 2026}
}

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