The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2593-2016·Announced 2016-08-24

Hospira Receptal Canisters Recalled Due to Incorrect Liner Size Usage

Hospira is recalling Receptal canisters and liners because customers may use incorrect liner sizes, potentially causing the lid to not fit properly and reducing vacuum suction.

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 source text does not report any illnesses or injuries. The hazard is related to improper function (vacuum/suction) rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Hospira Inc. is recalling Hospira RECEPTAL CANISTERS and associated liners in 1L, 1.5L, and 2L sizes. The recall involves specific list numbers including 43449, 43423, 43445, and 43496, with a total quantity of 67,410,861 liners and 67,410,861 lids/canisters. The products were distributed nationwide in the United States, including the District of Columbia and Puerto Rico, as well as in Australia, Canada, Costa Rica, Singapore, and South Africa.

The recall was initiated because Hospira became aware of customers using incorrect size Receptal liners with their Receptal canisters, such as using a 1.5L, 2L, or 3L liner with a 1L canister. If an incorrectly sized liner is used, the lid may not fit properly, and the vacuum or suction may not be sufficient or consistent.

This recall is classified as Class II by the FDA. There are no reported illnesses or injuries associated with this recall. Healthcare facilities and customers should stop using the affected products and contact Hospira for further instructions.

The recalled product

Product
Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE 2) List Numbers 43423-01 and…
Manufacturer
Hospira Inc.
Category
Medical Device — Wound Care / Drainage
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Hospira 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 2 products in this recall →

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