Candela recalls specific surgical laser coolant canisters due to risk of neck bushing separation in legacy devices. Affected units include certain lot numbers from 2018-2019.
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
Candela Corporation is recalling specific surgical laser coolant canisters that may have a loose neck bushing which could separate during use. This poses a risk when used in older devices with threaded connections. Affected units have specific lot numbers from 2018-2019.
The neck bushing in the canister may become loose and separate from the canister body during use. This only happens when the canisters are used in older Candela devices with threaded connections. The separation could cause the canister to malfunction or become unsafe.
Surgical laser users with Candela legacy devices that use threaded interface DCD modules are most at risk. The recall affects specific lot numbers of the 980g HFC-134a coolant canisters sold between 2018 and 2019.
Check for the product number 1600-00-0223 Revision .0C on the canister. Affected units include specific lot numbers listed in the recall notice from 2018 through 2019.
Look for lot numbers on the canister including 1904CC1598, 1905CC0007, and other specific numbers listed in the recall.
Reach out to Candela Corporation for guidance on whether your canister is affected and next steps.
The neck bushing may become loose and separate from the canister body during use in legacy devices with threaded connections.
No, but you should check if your canister has an affected lot number and contact Candela for guidance.
Only Candela legacy devices that use threaded interface DCD modules.
We’ve drafted a message you can send Candela to request your refund or repair — edit it as you like.
Subject: Recall Z-0208-2020 — Candela Candela Hello, I own a Candela that is covered by recall Z-0208-2020 from Candela. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
