Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1830-2015·Announced 2015-07-01

Cook Inc. Recalls LapSac Surgical Tissue Pouches Due to Labeling Error

Cook Inc. is recalling 123,184 LapSac Surgical Tissue Pouches because the labeling includes information not stated in the intended use.

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, but the specific hazard is a labeling error ('Includes Information not stated in the intended use') with no reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Cook Inc. is recalling 123,184 units of the LapSac Surgical Tissue Pouch. The device is a reinforced pouch with an inner liner and drawstring closure, intended for isolating tissue during or prior to surgical removal and/or morcellation. The recall is due to a labeling issue where the product includes information not stated in the intended use.

The affected devices were distributed worldwide, including nationwide in the United States and in several international markets. The recall covers multiple lot numbers across various product configurations, including the LapSac Surgical Tissue Pouch, LapSac Pre-Loaded Surgical Tissue Pouch Introducer, and LapSac Tissue Entrapment Pouch.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement.

The recalled product

Product: LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used…
Manufacturer: Cook Inc.
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling
Affected units: 123,184

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)

RPN: C-LSP-10-8
LapSac Surgical Tissue Pouch
LapSac Pre-Loaded Surgical Tissue Pouch Introducer
LapSac Tissue Entrapment Pouch
LapSac Tissue Entrapment Pouch Introducer
Lot Numbers: NS4993649
NS5439526
NS5068444
NS5145395
NS5423474
UF2481538
NS5257887
NS4966724
UF2282980
NS5477239
NS4945215
NS5054749
NS5012363
NS5835007
NS5047552

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Same manufacturer · Cook Inc.

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Same hazard · mis labeling