Class II — Candela Corporation
| Recalling firm | Candela Corporation |
|---|---|
| Registered facility | Candela Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser. |
| Quantity | in total 7,560 canisters (3240 additional as of 2/5/20) |
| Distribution | States: NC GA CA MA OH FL IL CO SD NY KS WA MI PA AZ WI TX LA IA MN VA TN SC OR IN WY MD VT ON BC QC NV OUS: Barbados Canada Germany Spain France HR Portugal Ireland Norway Greece NL South Africa Vietnam Hong Kong Japan New Zealand Australia China Korea |
| Initiated | 2019-09-10 |
| Classified | 2019-10-24 |
| Terminated | 2020-10-20 |
| Recall number | Z-0206-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Candela Corporation (Z-0206-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83839/
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