CLASS II ONGOING Device recall · Reported 10 May 2023 · FDA Enforcement Report
CryoTreQ- Aa disposable handheld instrument intended recalled
Beaver Visitec International is recalling CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery, distributed nationwide in the US. The recall was initiated on 17 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1497-2023
- FDA event ID
- 91986
- Recalling firm
- Beaver Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Mar 2023
- FDA classified
- 2 May 2023
- Reported
- 10 May 2023
- Type
- Voluntary: Firm initiated
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 17 Mar 2023 | Recall initiated by company | |
| 2 May 2023 | Classified by FDA | +46 days |
| 10 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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 tissue. Ref: CT00.D01
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery recalled?
Yes. Beaver Visitec International recalled CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery on 17 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1497-2023.
Why was it recalled?
Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.
Which lots are affected?
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, 20228657, 20228897, 20228898, 20229034, 20229138, 20229334, 20229460, 20229630, 20229748, 20230261, 20221083, 20221140, 20221364, 20221746, 20221894, 20222365
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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