Agency classClass IIOur severity:High FDA (Devices)·Z-0097-2015·Announced 2014-10-29

DeRoyal and Novaplus Suction Canisters Recalled for Insufficient Seal

DeRoyal Industries is recalling 13,900 non-sterile suction canisters and lids because they may have an insufficient seal under low or intermittent suction conditions.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

DeRoyal Industries Inc is voluntarily recalling 13,900 units of non-sterile, semi-rigid suction canisters and lids. The affected products are labeled as either DeRoyal(R) SUCTION CANISTER, 1000cc, REF 71-6510, or NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, Cat. No. V71-6510. The specific lots involved are 36408631 for the DeRoyal brand and 36408622 for the Novaplus brand.

The recall was initiated because these lots of suction canisters and lids have an insufficient seal under low or intermittent suction conditions. This defect could potentially affect the device's ability to maintain proper suction during use.

The products were distributed nationwide, including in Michigan, Ohio, Indiana, Florida, West Virginia, Virginia, North Carolina, and New York. Consumers and healthcare facilities should stop using these specific lots of suction canisters and lids and contact DeRoyal Industries Inc for further instructions or a replacement.

The recalled product

Product: Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Suction Canisters
Hazard: defective-seal
functional-failure
Affected units: 13,900

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)

1) DeRoyal(R)
REF 71-6510
Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510
Lot 36408622

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by DeRoyal Industries 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 →

Same manufacturer · DeRoyal Industries Inc

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Same hazard · defective seal