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Surgipro IIRecalls & reported problems across all models

Covidien LP · 73 models in the FDA device registry

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

1 open recall names at least one Surgipro II model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
782
Deaths reported
3
Injuries reported
78
Recalls
1

We found 73 models of Surgipro II by Covidien LP in the FDA's device registry (GUDID). Together they are named in 782 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2017 and Sep 18, 2026 — classified as 3 deaths, 78 injuries, 701 malfunctions.

The most frequently reported specific device problem is “Break” (611 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

Reports received per month, all models

Nov 2023: 9 reportsDec 2023: 21 reportsJan 2024: 12 reportsFeb 2024: 7 reportsMar 2024: 7 reportsApr 2024: 12 reportsMay 2024: 9 reportsJun 2024: 7 reportsJul 2024: 34 reportsAug 2024: 12 reportsSep 2024: 29 reportsOct 2024: 2 reportsNov 2024: 2 reportsDec 2024: 2 reportsJan 2025: 23 reportsFeb 2025: 2 reportsMar 2025: 10 reportsApr 2025: 4 reportsMay 2025: 6 reportsJun 2025: 16 reportsJul 2025: 16 reportsAug 2025: 1 reportsSep 2025: 6 reportsOct 2025: 8 reportsNov 2025: 9 reportsDec 2025: 6 reportsJan 2026: 4 reportsFeb 2026: 9 reportsMar 2026: 4 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 3 reportsJul 2026: 1 reportsAug 2026: 4 reportsSep 2026: 3 reportsOct 2026: 0 reports20242025202634
Last 36 months. The most recent month may be incomplete.

Surgipro II 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. Dec 2, 2022Open, Classified

    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

    Z-1180-2023 · Root cause: Packaging process control · names 7 of these models · Recall details · FDA record ↗

Most reported Surgipro II problems

Device problems

  • Break611
  • Detachment of Device or Device Component220
  • Adverse Event Without Identified Device or Use Problem22
  • Material Frayed15
  • Unraveled Material9
  • Insufficient Device Problem Information7
  • Dull, Blunt5
  • Manufacturing, Packaging or Shipping Problem5

Patient problems

  • No Clinical Signs, Symptoms or Conditions402
  • Insufficient Information130
  • No Consequences Or Impact To Patient114
  • No Known Impact Or Consequence To Patient73
  • Unintended Radiation Exposure36
  • Foreign Body In Patient23
  • Hemorrhage/Blood Loss/Bleeding20
  • No Code Available20

Surgipro II models

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

Recent Surgipro II adverse event reports

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

Other Covidien LP products

All Covidien LP devices →

Sources and updates

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