Canister HFC-134a /1000g — Class II medical device recall Z-0207-2020
Terminated recall by Candela Corporation, reported 2019-10-30, distributed in AZ, CA, CO, FL, GA, IA, IL, IN…. The canister neck bushing may become loose and separate from the body of the canister during use. The issue oc
| Recall number | Z-0207-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Candela Corporation, Wayland, MA, United States |
| Recall initiated | 2019-09-10 |
| Classified | 2019-10-24 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2020-10-20 |
| Distributed | AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, NC, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WY |
| Countries outside the US | AU, BB, CA, CN, DE, ES, FR, GR, HK, IE, JP, KR, NO, NZ, PT, VN, ZA |
| Lot numbers | 1904CC1598, 1905CC0007, 1905CC0178, 1905CC0217, 1906CC0172, 1906CC0196, 1907CC0008, 1908CC0025 |
Product
Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0207-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.