Recall Z-2445-2025 ยท EBA Light, Surgical Headlight
Orascoptic Surgical Acuity
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
| Date | Aug 26, 2025 (initiated Jul 3, 2025) |
| Status | Open, Classified |
| Reason | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| Root cause | Labeling design |
| Action | On June 24, 2025, Orascoptic Superior Visualization issued a Urgent: Loupe Advisory Notice. On July 7, 2025 a revised letter was issued to remove cleaning instructions. On August 13, 2025, Orascoptic Superior Visualization issued an Urgent: Medical Device Recall expansion notification to include additional nose pad accessory kits and additional information on the reason for recall, the risk to patient and the steps that should be taken. Orascoptic asked consignees to take the following actions: 1. To confirm if your loupe is subject to this notice, please visit orascoptic.com website to s |
| Quantity | 22 kits. |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.