FDA Device recall Z-0406-2017
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014 by C R Bard, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0406-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-13 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | US |
Product
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Reason
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.
Identifiers
| code_info | Product Codes: REK32N and FEK32HW. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0406-2017%22
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