CLASS III Device recall · Reported 10 Apr 2019 · FDA Enforcement Report

Micro Knife 30¿ recalled by Beaver Visitec

Beaver Visitec is recalling Micro Knife 30¿, distributed nationwide in the US. The recall was initiated on 19 Feb 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Number 180615

Quantity recalled97 boxes (10units/box)

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-1088-2019
FDA event ID: 82248
Recalling firm: Beaver Visitec, Waltham, MA
Classification: Class III
Status: Terminated
Recall initiated: 19 Feb 2019
FDA classified: 4 Apr 2019
Reported: 10 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

19 Feb 2019	Recall initiated by company
4 Apr 2019	Classified by FDA	+44 days
10 Apr 2019	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 product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.

Product as listed by the FDA

Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .

Where it was distributed

US Nationwide Distribution to states of : AL, AZ, CA, FL, ID, MN, MO, NY, OH, PA, and TX; and internationally to: Ireland and UK.

Nationwide Alabama Arizona California Florida Idaho Minnesota Missouri New York Ohio Pennsylvania Texas

Questions about this recall

Why was it recalled?

The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.

Which lots are affected?

Lot Number 180615

Where was it sold?

US Nationwide Distribution to states of : AL, AZ, CA, FL, ID, MN, MO, NY, OH, PA, and TX; and internationally to: Ireland and UK.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Beaver Visitec

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19 Sep 2018Device	CLASS II	Beaver Accu-Temp High Temperature Cautery Shaft with Fine Tip recalled	Beaver Visitec	Sterility	Nationwide
15 Aug 2018Device	CLASS II	Slit Knife 45degree Bevel Up recalled by Beaver Visitec	Beaver Visitec	Labeling Errors	7 states
11 Jul 2018Device	CLASS II	Safety Sideport Knife 45¿ recalled by Beaver Visitec	Beaver Visitec	Other	Nationwide

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