CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
Orascoptic Superior Visualization Custom loupes recalled
Orascoptic Surgical Acuity is recalling Orascoptic Superior Visualization Custom loupes with Dragonfly frames, distributed nationwide in the US. The recall was initiated on 3 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2440-2025
- FDA event ID
- 97260
- Recalling firm
- Orascoptic Surgical Acuity, Orange, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jul 2025
- FDA classified
- 26 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jul 2025 | Recall initiated by company | |
| 26 Aug 2025 | Classified by FDA | +54 days |
| 3 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Product as listed by the FDA
Orascoptic Superior Visualization Custom loupes with Dragonfly frames
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Orascoptic Superior Visualization Custom loupes with Dragonfly frames recalled?
Yes. Orascoptic Surgical Acuity recalled Orascoptic Superior Visualization Custom loupes with Dragonfly frames on 3 Jul 2025. The recall is Class II and its status is Ongoing. Recall number Z-2440-2025.
Why was it recalled?
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Which lots are affected?
All Serial numbers manufactured between September 7, 2023 - May 14, 2025
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Orascoptic Surgical Acuity
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Orascoptic Superior Visualization Phantom Essential kit recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Custom loupes configured recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Dragonfly Nose Pad recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Phantom Nose Pad recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Dragonfly Essentials Kit recalled | Orascoptic Surgical Acuity | Other | Nationwide |
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