Z-2442-2025Class II
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side...
Orascoptic Surgical Acuity / initiated 2025-07-03 / Open, Classified / root cause: labeling and UDI
Orascoptic Surgical Acuity began a recall of Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) on . 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 , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2442-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Orascoptic Surgical Acuity
- Product
- Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
- 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
- 32 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, 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 kits manufactured between June 6, 2023 - May 14, 2025
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2440-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2441-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2442-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2443-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2444-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2445-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.