# FDA recall Z-0207-2020

> **Candela Corporation** · Class II · device recall initiated 2019-09-10.

## 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

## 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

## Key facts

- **Recall number:** Z-0207-2020
- **Recalling firm:** Candela Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-10
- **Report date:** 2019-10-30
- **Termination date:** 2020-10-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayland, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0207-2020

## Citation

> AI Analytics. FDA recall Z-0207-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0207-2020. Source: US FDA. Licensed CC0.

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