Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0136-2015·Announced 2014-11-05

Animas Vibe Insulin Pump Recalled for Incorrect Hebrew Translation

Animas Corporation is recalling 1,028 Vibe Insulin Infusion Pumps in Israel due to incorrect Hebrew language translations and omitted text on the display screen.

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 classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is incorrect labeling/translation leading to potential confusion, which aligns with the 'Moderate' criteria for labeling errors without reported serious injury.

Plain-English summary

Animas Corporation is recalling 1,028 units of the Vibe Insulin Infusion Pump. The recall is limited to international distribution in Israel. The product is indicated for the continuous subcutaneous infusion of insulin for the treatment of diabetes and includes a continuous glucose monitoring feature.

The recall was initiated because Animas determined that the Hebrew language translation on the pump was incorrect. Additionally, one line of Hebrew text was omitted from the display screen. These errors could lead to potential patient confusion.

Consumers in Israel who possess the affected model numbers should contact Animas Corporation for further instructions. The affected model numbers include various PMPW/OKIT, REV KIT, and VIBEPL configurations ending in 'mg,IL'.

The recalled product

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.
Manufacturer: Animas Corporation
Category: Medical Device — Insulin Pump
Hazard: mis-labeling
user-confusion
Affected units: 1,028

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 (20)

Model Number(s): 11220008 PMPW/OKIT
VIBE
BLU
mg
IL 11220108 PMPW/OKIT
BLK
IL 11220208 PMPW/OKIT
SIL
IL 11220408 PMPW/OKIT
PGL
IL 11220508 PMPW/OKIT
LGN
IL 11251008 REV KIT
IL 11251108 REV KIT
IL 11251208 REV KIT
IL 11251408 REV KIT
IL 11251508 REV KIT
IL 11451008 REV KIT
VIBEPL
IL 11451108 REV KIT

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Animas Corporation

See all →

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Severe
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High
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Moderate
Animas Insulin Pumps Recalled for Keypad Wear and Peeling
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Same hazard · mis labeling