Z-2441-2025Class II

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Name: Z-2441-2025 Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Creator: Orascoptic Surgical Acuity
Published: 2025-07-03
License: https://open.fda.gov/license/

Orascoptic Surgical Acuity / initiated 2025-07-03 / Open, Classified / root cause: labeling and UDI

FDA source

Orascoptic Surgical Acuity began a recall of Orascoptic Superior Visualization Custom loupes configured with Phantom Frames on 2025-07-03. FDA classified it as Class II and gives the reason as "Due to complaints, loupe nose pads containing nickel may cause an allergic reaction". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2441-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-03
Posted: 2025-08-26
Recalling firm: Orascoptic Surgical Acuity
Product: Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Product code: EBA Light, Surgical Headlight
Reason for recall: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 10,611 units
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, 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.
Product codes and lots: All serial numbers manufactured between June 6, 2023 - May 14, 2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2441-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2440-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26
Z-2441-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26
Z-2442-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26
Z-2443-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26
Z-2444-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26
Z-2445-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26

Product code EBA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)