The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0406-2017·Announced 2016-11-23

C.R. Bard Recalls Totalis Endo Kits for Labeling Update

C.R. Bard is recalling 75,089 Totalis endo kits to add a warning about potential knots during removal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is for a labeling update to address a potential mechanical issue (knotting) during removal, which fits the criteria for moderate severity involving minor labeling errors or precautionary measures without reported injuries.

Plain-English summary

C.R. Bard, Inc. is recalling 75,089 units of Totalis, RIGID, and Totalis"I Flex ENDO KITs. The recall is due to a labeling issue where a statement was added to the Warnings/Precautions section. The new statement requests end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

The affected products are distributed nationwide in the United States. The specific product codes involved are REK32N and FEK32HW. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and end users should review the updated labeling information. If you have questions about this recall or the affected products, contact the manufacturer, C.R. Bard, Inc., in Covington, GA.

The recalled product

Product
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
75,089

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Codes: REK32N and FEK32HW.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by C.R. Bard, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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