The Recall Desk
HighFDA (Devices)·Z-0209-2020·Announced 2019-10-30

Candela Surgical Laser Coolant Canisters Recalled for Loose Bushing

Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may separate during use in specific legacy devices.

What this means for you

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 defect presents a risk of harm (component separation) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Candela Corporation is recalling HFC-134a coolant canisters (Product Number 1600-00-0224, Revision .0C) used with surgical lasers. The recall involves 7,560 canisters in total, with an additional 3,240 units added as of February 5, 2020.

The recall is due to a defect where the canister neck bushing may become loose and separate from the body of the canister during use. This issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules.

The affected canisters were distributed to various states in the United States and to multiple international locations, including Canada, Germany, Spain, France, and others. Specific lot numbers are listed in the official recall documentation. Users of these devices should stop using the affected canisters and contact Candela Corporation for further instructions.

The recalled product

Product
Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
Manufacturer
Candela Corporation
Category
Medical Device — Surgical Laser Accessories
Hazard

Distribution

Distributed in 28 states:

Part of a larger recall action

This product is one of 4 recalled by Candela Corporation 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 4 products in this recall →

Related recalls

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Same hazard · component separation

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