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RecallWatchMedical Device Safety
Root cause

Employee error

An FDA-recorded root-cause determination. The FDA lists 18 recalls with this root cause since 2025. Most recent report: Oct 7, 2026.

Class II: 18

Latest recalls

View all 18 in the recall browser →
Class IIOngoingZ-1250-2026

Vortex Surgical Inc. recalls Vortex Surgical 25GA I.D.D. Internal Delivery Device

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

  • Polyvinyl Acetal Posterior Capsular Polishing Ophthalmic Cannula
  • Employee error
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1251-2026

Vortex Surgical Inc. recalls Tecfen Retractable Membrane Polisher

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

  • Ophthalmic Hook
  • Employee error
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1248-2026

Vortex Surgical Inc. recalls 25GA Subretinal Injection Cannula VS0220.25

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

  • Polyvinyl Acetal Posterior Capsular Polishing Ophthalmic Cannula
  • Employee error
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1252-2026

Vortex Surgical Inc. recalls Vortex Surgical I2 Injection Kit

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

  • Disposable Surgical Instrument Kit
  • Employee error
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1255-2026

Vortex Surgical Inc. recalls Vortex Surgical 25GA Backflush

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

  • Polyvinyl Acetal Posterior Capsular Polishing Ophthalmic Cannula
  • Employee error
Vortex Surgical Inc.MOFeb 11, 2026

Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.