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Ambler Surgical
AMBLER SURGICAL CORP. · Model Shepard incision irrigating cannula · UDI-DI 00190660202170
HMX
Prescription
10
510(k) clearances
801
Adverse events
28
Recalls
236
Facilities
Description
Shepard incision irrigating cannula, 25 gauge, angled, flattened tip, blunt end opening, 5.0mm from bend to tip, 19.0mm overall length excluding hub
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-06 | Iantrek Inc. | Potential for compromised integrity of the sterile packaging. |
| 2024-02-02 | Beaver Visitec International, Inc. | Pack and pouch label is missing the manufacturing and expiration date. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2021-04-21 | Anodyne Surgical | The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. |
| 2021-02-25 | Dutch 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 |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
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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.