CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report

Totalis, Rigid and Totalis"I Flex Endo Kit, Manufacturer: C.R recalled

C.R. Bard is recalling Totalis, Rigid and Totalis"I Flex Endo Kit, Manufacturer: C.R, distributed nationwide in the US. The recall was initiated on 13 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Codes: REK32N and FEK32HW.

Quantity recalled75,089 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-0406-2017
FDA event ID: 75492
Recalling firm: C.R. Bard, Covington, GA
Classification: Class II
Status: Terminated
Recall initiated: 13 Oct 2016
FDA classified: 14 Nov 2016
Reported: 23 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Oct 2016	Recall initiated by company
14 Nov 2016	Classified by FDA	+32 days
23 Nov 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Product as listed by the FDA

Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Where it was distributed

U.S. Nationwide.

Nationwide

Questions about this recall

Is Totalis, Rigid and Totalis"I Flex Endo Kit, Manufacturer: C.R recalled?

Yes. C.R. Bard recalled Totalis, Rigid and Totalis"I Flex Endo Kit, Manufacturer: C.R on 13 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0406-2017.

Why was it recalled?

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Which lots are affected?

Product Codes: REK32N and FEK32HW.

Where was it sold?

U.S. Nationwide.

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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