CLASS II ONGOING Device recall · Reported 26 Jun 2024 · FDA Enforcement Report
Xstar Safety Slit Knife 45¿ Bevel Up recalled
Beaver Visitec International is recalling Xstar Safety Slit Knife 45¿ Bevel Up, distributed nationwide in the US. The recall was initiated on 10 May 2024 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-2162-2024
- FDA event ID
- 94645
- Recalling firm
- Beaver Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 May 2024
- FDA classified
- 20 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 10 May 2024 | Recall initiated by company | |
| 20 Jun 2024 | Classified by FDA | +41 days |
| 26 Jun 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
Questions about this recall
Is Xstar Safety Slit Knife 45¿ Bevel Up recalled?
Yes. Beaver Visitec International recalled Xstar Safety Slit Knife 45¿ Bevel Up on 10 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2162-2024.
Why was it recalled?
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
Which lots are affected?
Xstar Safety Slit Knife: UDI-DI: 00886158001652; Lot Number: 6058854; CustomEye Kit # 584562 , lot # 6068524; CustomEye Kit # 584562 , lot # 6068025; CustomEye Kit # 5800109, lot # 6068285
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
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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