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CoonsRecalls & reported problems across all models

Cook Incorporated · 14 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name at least one Coons model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
15
Deaths reported
0
Injuries reported
3
Recalls
2

We found 14 models of Coons by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2016 and Jul 28, 2022 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (7 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Coons recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Mar 1, 2024Open, Classified

    Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

    Z-1532-2024 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗

  2. Aug 16, 2022Open, Classified

    Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

    Z-1828-2022 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

Most reported Coons problems

Device problems

  • Unraveled Material7
  • Difficult to Remove3
  • Unsealed Device Packaging2
  • Device Contaminated During Manufacture or Shipping1
  • Device Damaged Prior to Receipt by User1
  • Material Deformation1
  • Material Fragmentation1
  • Material Protrusion/Extrusion1

Patient problems

  • No Known Impact Or Consequence To Patient6
  • No Clinical Signs, Symptoms or Conditions3
  • No Code Available3
  • No Patient Involvement2
  • No Consequences Or Impact To Patient1

Coons models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Coons adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Cook Incorporated products

All Cook Incorporated devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page