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Hayden Medical

Hayden Medical, Inc. · Model E3-2695 · UDI-DI 00840319726327

HNQ Prescription
10
510(k) clearances
109
Adverse events
4
Recalls
187
Facilities

Description

Deitz ICL Manipulator Vertical blunt Y-shaped tip, angled 11mm from bend to tip, round knurled handle, 120mm overall length, stainless steel

Recalls

DateFirmReason
2025-12-16Vortex Surgical Inc.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
2025-12-16Vortex Surgical Inc.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
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2022-03-16Carl Zeiss Meditec AGHigh friction of the slider can cause the device to stick, or not move as intended.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.