Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-2443-2025

Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Phantom Essential kit ( Nose pad

Orascoptic Surgical AcuityOrange, CA, United StatesReported Sep 3, 2025 · 10 months ago
Legal News Analyst ·

Reason for recall

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

Lot / code information

All kits manufactured between June 6, 2023 - May 14, 2025

What the firm is doing

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 search the serial number. " Dragonfly loupe: the serial number is printed on the inside of the right temple arm. " Phantom sport frame: the serial number is printed on the loupe case name badge plate. 2. If you have given your custom loupe to someone else, please forward a copy of this notice to that person. 3. To request a replacement nose pad that does not contain nickel, please visit orascoptic.com. 4. Visit Orascoptic.com for directions on how to replace the nose pad for your frame. Contact technical support if you need additional support at 800.369.3698. Please discard the old nose pad. 5. Acknowledge receipt of this notice and contacting Orascoptic.

DistributionShow details

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, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls