CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report

Beaver Accu-Temp High Temperature Cautery Shaft with Fine Tip recalled

Beaver Visitec is recalling Beaver Accu-Temp High Temperature Cautery Shaft with Fine Tip, distributed nationwide in the US. The recall was initiated on 19 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 6002809, UDI 8445000 30886158010297

Quantity recalled800 units

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-3045-2018
FDA event ID: 80846
Recalling firm: Beaver Visitec, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Jul 2018
FDA classified: 13 Sep 2018
Reported: 19 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

19 Jul 2018	Recall initiated by company
13 Sep 2018	Classified by FDA	+56 days
19 Sep 2018	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

A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and plastic surgery.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of: CA, DC, FL, IA, ID, IL, MA, MI, MN, NY, OK, PA, TN, TX, UT, and WA and the countries of Australia, France, Netherlands, Spain, and United Kingdom.

Nationwide California District of Columbia Florida Iowa Idaho Illinois Massachusetts Michigan Minnesota New York Oklahoma Pennsylvania Tennessee Texas Utah Washington

Questions about this recall

Is Beaver Accu-Temp High Temperature Cautery Shaft with Fine Tip recalled?

Yes. Beaver Visitec recalled Beaver Accu-Temp High Temperature Cautery Shaft with Fine Tip on 19 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3045-2018.

Why was it recalled?

Which lots are affected?

Lot 6002809, UDI 8445000 30886158010297

Where was it sold?

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.

More recalls from Beaver Visitec

All 6

Reported	Class	Recall	Company	Reason	Where
17 Apr 2019Device	CLASS II	Beaver Xstar Slit Knife, 45degree Double Bevel recalled	Beaver Visitec	Labeling Errors	Nationwide
10 Apr 2019Device	CLASS III	Micro Knife 30¿ recalled by Beaver Visitec	Beaver Visitec	Other	Nationwide
3 Apr 2019Device	CLASS II	BVI Visitec Soft Tip Cannula .50 recalled by Beaver Visitec	Beaver Visitec	Foreign Material	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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