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Use caution Medical device recall · FDA · Published March 17, 2023

Beaver Visitec CryoTreQ-Aa Ophthalmic Surgery Device Recall: Risk of Sudden Disassembly

Beaver Visitec recalls CryoTreQ-Aa disposable handheld ophthalmic surgery devices that may suddenly disassemble during cryotherapy, potentially causing permanent injury. Affected lots listed in the recall.

🇺🇸 FDA recall #Z-1497-2023Medical deviceBeaver Visitec ›
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Contact the company

Recalling firmBeaver Visitec International, Inc.500 Totten Pond Rd, 10 City Point · Waltham, MA 02451-1916
✎ GovInfoNow plain-language explainer

Beaver Visitec recalls CryoTreQ-Aa disposable handheld instruments used in eye surgery that can suddenly and forcefully disassemble during procedures, risking permanent injury to patients or users. This recall affects specific production lots sold between 2021 and 2023. Read more at govinfonow.com/recall/58749-beaver-visitec-cryotreq-aa-ophthalmic-surgery-device-recall-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/58749-beaver-visitec-cryotreq-aa-ophthalmic-surgery-device-recall-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1497-2023

Cite this page

“Beaver Visitec CryoTreQ-Aa Ophthalmic Surgery Device Recall: Risk of Sudden Disassembly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58749-beaver-visitec-cryotreq-aa-ophthalmic-surgery-device-recall-risk-of. Based on FDA recall #Z-1497-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1497-2023%22&limit=1).

The FDA announced on March 17, 2023, that Beaver Visitec International, Inc. is recalling CryoTreQ-Aa disposable handheld instruments due to a potential for sudden disassembly during ophthalmic surgery. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Beaver Visitec
  • Product: CryoTreQ-Aa disposable handheld instrument
  • UPC: 08719214223458
  • Lots: 20214450, 20214366, 20214367, 20214518, 20214522, 20214615, 20214744, 20214745, 20214961, 20214962, 20215203, 20215204, 20215479, 20216263, 20216264, 20216010, 20227952, 20227950, 20227951, 20228408, 20228657, 20228897, 20228898, 20229034, 20229138, 20229334, 20229460, 20229630, 20229748, 20230261, 20221083, 20221140, 20221364, 20221746, 20221894, 20222365
  • Distribution: US Nationwide

The hazard

The device may suddenly and forcefully disassemble after cryotherapy. This failure poses a potential for long-term or permanent impairment of a patient or user if the device breaks during a cryosurgery procedure.

Context

GovInfoNow's records show Beaver-Visitec International, Inc. has 15 other recalls on record since November 3, 2017. Other recent recalls of similar products include Katalyst Surgical DEX Ophthalmic Tissue Forceps Recall (March 25, 2026), Erbe Flexible Cryoprobe Recall (February 12, 2026), and Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026).

How to tell if you have this one

Check for the product name 'CryoTreQ-Aa' on the device. Affected lots include specific numbers listed in the recall (e.g., 20214450, 20214366, etc.) sold between 2021 and 2023.

  • Brand
    Beaver Visitec
  • Product
    Beaver Visitec International, Inc. recalls CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic…
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Lot Number

    Look for the lot number on the device packaging or label to see if it matches the affected lots listed in the recall.

  2. Contact Manufacturer

    Reach out to Beaver Visitec International, Inc. for guidance on next steps if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Mar 17, 202312. FDA classified it Class II: May 2, 202323. Published in FDA’s Enforcement Report: May 10, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The device has a risk of sudden disassembly during surgery, which could cause permanent injury. It is not safe to use without checking if it's in an affected lot.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1497-2023 (March 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1497-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA