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U.S. Department of Health and Human Services

Class 2 Device Recall Phantom Essential Kit

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 Class 2 Device Recall Phantom Essential Kitsee related information
Date Initiated by FirmJuly 03, 2025
Date PostedAugust 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2443-2025
Recall Event ID 97260
Product Classification Light, surgical headlight - Product Code EBA
ProductOrascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Code Information All kits manufactured between June 6, 2023 - May 14, 2025
FEI Number 3007515681
Recalling Firm/
Manufacturer		 Orascoptic Surgical Acuity
717 W Collins Ave
Orange CA 92867-5513
For Additional Information ContactNorth America Customer Care & Technical Support
800-369-3698
Manufacturer Reason
for Recall		Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
FDA Determined
Cause 2		Labeling design
ActionOn 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 Commerce74 kits
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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