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Sklar InstrumentsRecalls & reported problems across all models

Sklar Corporation · 205 models in the FDA device registry

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

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls
14

We found 205 models of Sklar Instruments by Sklar Corporation in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jun 25, 2025 and Aug 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

14 FDA recall records name at least one of these models by its device identifier, 14 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: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Sklar Instruments 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 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0954-2025 · Root cause: Under Investigation by firm · names 28 of these models · Recall details · FDA record ↗

  2. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0953-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  3. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0951-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  4. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0950-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

  5. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0944-2025 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗

  6. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0943-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  7. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0941-2025 · Root cause: Under Investigation by firm · names 76 of these models · Recall details · FDA record ↗

  8. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0939-2025 · Root cause: Under Investigation by firm · names 68 of these models · Recall details · FDA record ↗

  9. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0935-2025 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

  10. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0934-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  11. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0933-2025 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

  12. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0932-2025 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

  13. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0931-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  14. Dec 3, 2024Open, Classified

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Z-0929-2025 · Root cause: Under Investigation by firm · names 8 of these models · Recall details · FDA record ↗

Most reported Sklar Instruments problems

Device problems

  • Tear, Rip or Hole in Device Packaging2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Sklar Instruments models

205 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Sklar Instruments adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

Sources and updates

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