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Hayden Medical

Hayden Medical, Inc. · Model E7-2278 · UDI-DI 00840319727447

HMX Prescription
10
510(k) clearances
801
Adverse events
28
Recalls
236
Facilities

Description

Hydrodissection Cannula 27ga Angled 8mm from bend to tip, flat tip, 22mm overall length

Recalls

DateFirmReason
2025-09-06Iantrek Inc.Potential for compromised integrity of the sterile packaging.
2024-02-02Beaver Visitec International, Inc.Pack and pouch label is missing the manufacturing and expiration date.
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-04-21Anodyne SurgicalThe product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
2021-02-25Dutch Ophthalmic USA, Inc.Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281
2019-12-17Vitreq BvMicroscopic tears of the sterile pouch may compromise sterility
2019-12-17Vitreq BvMicroscopic tears of the sterile pouch may compromise sterility
2019-12-17Vitreq BvMicroscopic tears of the sterile pouch may compromise sterility
2019-12-17Vitreq BvMicroscopic tears of the sterile pouch may compromise sterility
2019-12-17Vitreq BvMicroscopic tears of the sterile pouch may compromise sterility

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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.