FDA Device recall Z-0136-2015

Animas Vibe Insulin Infusion Pump

FDA Device
Class II
terminated
Published 2014-11-05

On 2014-11-05 the FDA classified a Class II recall of Animas Vibe Insulin Infusion Pump by Animas, citing animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebr….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0136-2015
Classification	Class II
Status	terminated
Initiated	2014-06-10
Published	2014-11-05
Last updated	2026-09-13 11:53 UTC
Company	Animas
Distribution	n/a

Product

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

Reason

Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.

Identifiers

code_info	Model Number(s): 11220008 PMPW/OKIT,VIBE,BLU,mg,IL 11220108 PMPW/OKIT,VIBE,BLK,mg,IL 11220208 PMPW/OKIT,VIBE,SIL,mg,… Model Number(s): 11220008 PMPW/OKIT,VIBE,BLU,mg,IL 11220108 PMPW/OKIT,VIBE,BLK,mg,IL 11220208 PMPW/OKIT,VIBE,SIL,mg,IL 11220408 PMPW/OKIT,VIBE,PGL,mg,IL 11220508 PMPW/OKIT,VIBE,LGN,mg,IL 11251008 REV KIT,VIBE,BLU,mg,IL 11251108 REV KIT,VIBE,BLK,mg,IL 11251208 REV KIT,VIBE,SIL,mg,IL 11251408 REV KIT,VIBE,PGL,mg,IL 11251508 REV KIT,VIBE,LGN,mg,IL 11451008 REV KIT,VIBEPL,BLU,mg,IL 11451108 REV KIT,VIBEPL,BLK,mg,IL 11451208 REV KIT,VIBEPL,SIL,mg,IL 11451408 REV KIT,VIBEPL,PGL,mg, IL 11451508 REV KIT,VIBEPL,LGN,mg,IL 11420008 PMPW/OKIT,VIBEPL,BLU,mg,IL 11420108 PMPW/OKIT,VIBEPL,BLK,mg,IL 11420208 PMPW/OKIT,VIBEPL,SIL,mg,IL 11420408 PMPW/OKIT,VIBEPL,PGL,mg,IL 11420508 PMPW/OKIT,VIBEPL,LGN,mg,IL

code_info

Model Number(s): 11220008 PMPW/OKIT,VIBE,BLU,mg,IL 11220108 PMPW/OKIT,VIBE,BLK,mg,IL 11220208 PMPW/OKIT,VIBE,SIL,mg,…

Model Number(s): 11220008 PMPW/OKIT,VIBE,BLU,mg,IL 11220108 PMPW/OKIT,VIBE,BLK,mg,IL 11220208 PMPW/OKIT,VIBE,SIL,mg,IL 11220408 PMPW/OKIT,VIBE,PGL,mg,IL 11220508 PMPW/OKIT,VIBE,LGN,mg,IL 11251008 REV KIT,VIBE,BLU,mg,IL 11251108 REV KIT,VIBE,BLK,mg,IL 11251208 REV KIT,VIBE,SIL,mg,IL 11251408 REV KIT,VIBE,PGL,mg,IL 11251508 REV KIT,VIBE,LGN,mg,IL 11451008 REV KIT,VIBEPL,BLU,mg,IL 11451108 REV KIT,VIBEPL,BLK,mg,IL 11451208 REV KIT,VIBEPL,SIL,mg,IL 11451408 REV KIT,VIBEPL,PGL,mg, IL 11451508 REV KIT,VIBEPL,LGN,mg,IL 11420008 PMPW/OKIT,VIBEPL,BLU,mg,IL 11420108 PMPW/OKIT,VIBEPL,BLK,mg,IL 11420208 PMPW/OKIT,VIBEPL,SIL,mg,IL 11420408 PMPW/OKIT,VIBEPL,PGL,mg,IL 11420508 PMPW/OKIT,VIBEPL,LGN,mg,IL

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0136-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.