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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97260

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 03, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Orascoptic Surgical Acuity

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Orascoptic Superior Visualization Custom loupes with Dragonfly frames

Z-2440-2025
Recall number
Z-2440-2025
Initiated
July 03, 2025
Classification
Class II
Status
Ongoing
Quantity
15,245 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All Serial numbers manufactured between September 7, 2023 - May 14, 2025

Distribution pattern

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.

device · product 2 of 6

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Z-2441-2025
Recall number
Z-2441-2025
Initiated
July 03, 2025
Classification
Class II
Status
Ongoing
Quantity
10,611 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All serial numbers manufactured between June 6, 2023 - May 14, 2025

Distribution pattern

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.

device · product 3 of 6

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

Z-2442-2025
Recall number
Z-2442-2025
Initiated
July 03, 2025
Classification
Class II
Status
Ongoing
Quantity
32 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 4 of 6

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

Z-2443-2025
Recall number
Z-2443-2025
Initiated
July 03, 2025
Classification
Class II
Status
Ongoing
Quantity
74 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 5 of 6

Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.

Z-2444-2025
Recall number
Z-2444-2025
Initiated
July 03, 2025
Classification
Class II
Status
Ongoing
Quantity
743 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 6 of 6

Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.

Z-2445-2025
Recall number
Z-2445-2025
Initiated
July 03, 2025
Classification
Class II
Status
Ongoing
Quantity
22 kits.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.