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AMBLER SURGICAL CORP. · Model Castroviejo needle holder · UDI-DI 00190660196691
HNR
Prescription
10
510(k) clearances
888
Adverse events
16
Recalls
279
Facilities
Description
Castroviejo needle holder, 5 3/8'', straight, standard 12.0mm jaws, flat handle, with lock, economy pattern recommended for clinics/mission trips only
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| 2026-03-25 | Katalyst Surgical, LLC | Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding |
| 2026-03-25 | Katalyst Surgical, LLC | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
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Get your free API keyRead the docsData 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.
