CryoTreQ Aa ophthalmic instrument recalled for risk of sudden disassembly
Beaver Visitec is recalling the CryoTreQ Aa ophthalmic surgical instrument due to risk of sudden disassembly during use. Device disassembly during cryosurgery could cause permanent vision impairment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm device with potential for permanent impairment if disassembly occurs during ophthalmic surgery. No illnesses or injuries have been reported. The score is 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beaver Visitec International, Inc. is recalling the CryoTreQ Aa, a disposable handheld instrument used in ophthalmic surgery. The device uses cryogenic temperatures created by nitrous oxide evaporation to perform cryotherapy and tissue coagulation. Approximately 501 units were distributed nationwide in the United States.
The device may suddenly and forcefully disassemble during or after cryotherapy procedures. If disassembly occurs during cryosurgery on the eye, it could potentially result in long-term or permanent vision impairment for the patient.
Patients who have received or may receive treatment with this device should contact their healthcare provider. Healthcare providers using affected lot numbers should immediately cease use and contact Beaver Visitec International, Inc. for device replacement or alternative procedure options.
The recalled product
- Product
- CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissu
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- device-disassembly
- permanent-impairment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN: 08719214223458 All Affected Lots: 20214450
- 20214366
- 20214367
- 20214518
- 20214522
- 20214615
- 20214744
- 20214745
- 20214961
- 20214962
- 20215203
- 20215204
- 20215479
- 20216263
- 20216264
- 20216010
- 20227952
- 20227950
- 20227951
- 20228408
Distribution
Distributed nationwide across the United States.
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