Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2178-2017·Announced 2017-06-07

AbbVie Recalls PEG Kits Due to Missing or Duplicate Components

AbbVie is recalling 3,331 PEG kits distributed in the US and 31 other countries because they may have missing components, duplicate parts, or missing labels.

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, and the defects involve missing or duplicate components and labeling errors. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving potential misuse or administrative errors.

Plain-English summary

AbbVie Inc. is recalling 3,331 units of the PEG Kit 15FR, a sterile medical device intended for enteral use. The recall is due to potential defects in the kits, which may include missing components, duplicate components, or missing labels and Instructions for Use that contain expiry information.

The affected product is identified by Material/List number 62918001 and lots 32044225, 32155205, 32344326, and 32461215. The kits were distributed nationwide in the United States as well as in Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Norway, Portugal, Romania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, and Turkey.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If the product matches the recalled description, it should be removed from use and returned to the supplier or the manufacturer for further instructions.

The recalled product

Product: AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Manufacturer: AbbVie Inc.
Category: Medical Device — Enteral Feeding Devices
Hazard: missing-components
duplicate-components
mis-labeling
Affected units: 3,331

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 (4)

Material/List number: 62918001 Lots: 32044225
32155205
32344326
32461215

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by AbbVie 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 3 products in this recall →

Same manufacturer · AbbVie Inc.

See all →

Moderate
Pred Mild prednisolone eye suspension failed stability specifications
FDA (Drugs) · 2026-06-03
High
Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach
FDA (Drugs) · 2024-10-02
High
FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach
FDA (Drugs) · 2024-10-02
High
Synthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling
FDA (Drugs) · 2023-11-15
Low
AbbVie Recalls Ultane Sevoflurane Due to Defective Container Caps
FDA (Drugs) · 2018-02-07

Same hazard · missing components