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Endo Assist Neon Blue
ZIRC DENTAL PRODUCTS, INC. · Model 50Z460N · UDI-DI 00840161302076
FSM
Prescription
10
510(k) clearances
2,357
Adverse events (2 deaths)
40
Recalls
876
Facilities
Description
"Built-in millimeter gauge measures files and positions rubber stopper Right or left hand use Small and large rings are included to accommodate most finger sizes Flat bottom enables the Endo Assist to stand freely on its own Comes with 12 disposable foam inserts Foam cleans and holds files Designed to slide into side of the Endo Guards Dimensions: 1-1/2"" x 1-3/4"" x 1-5/8"" Autoclavable up to 136°C/275°F Washer-disinfect"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2025-07-18 | Encore Medical, LP | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| 2024-06-11 | Medical Action Industries, Inc. 306 | The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foa |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile |
| 2023-02-23 | Aesculap Implant Systems LLC | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
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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.