CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report
Canister Hfc-134a /, Alum Product Number recalled by Candela
Candela is recalling Canister Hfc-134a /, Alum Product Number: 1600-00-0224 Revision .0C Coolant canister for, distributed in 26 states. The recall was initiated on 10 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0209-2020
- FDA event ID
- 83839
- Recalling firm
- Candela, Wayland, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2019
- FDA classified
- 24 Oct 2019
- Reported
- 30 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 10 Sep 2019 | Recall initiated by company | |
| 24 Oct 2019 | Classified by FDA | +44 days |
| 30 Oct 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
Where it was distributed
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
ArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisKansasLouisianaMassachusettsMarylandMichiganMinnesotaNorth CarolinaNevadaNew YorkPennsylvaniaSouth CarolinaSouth DakotaTennessee
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot # 1904CC1598 1905CC0007 1905CC0178 1905CC0217 1906CC0196 1906CC0172 1907CC0008 1908CC0025 Additional lots added as of 12/6/2019: 1902CC0043 1902CC0143 1811CC0016 1812CC0074 1812CC0133 1901CC0087 1904CC0126 1802CC0092 1802CC0232 1803CC0169 1804CC0073 1805CC0058 1806CC0068 1807CC0009 1807CC0104 1808CC0112 1809CC0070 1810CC0015 1810CC0117 1907CC0187
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 83839This product is part of a recall event; the main page for the event is Canister Hfc-134a /, Alum Product Number recalled by Candela.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Canister Hfc-134a /, Alum Product Number recalled by Candela | Candela | Other | 26 states | |
| CLASS II | Canister Hfc-134a /, Alum Product Number recalled by Candela | Candela | Other | 26 states | |
| CLASS II | Canister Hfc-134a /, Alum Product Number recalled by Candela | Candela | Other | 26 states |
More recalls from Candela
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Canister Hfc-134a /, Alum Product Number recalled by Candela | Candela | Other | 26 states |
| Device | CLASS II | Canister Hfc-134a /, Alum Product Number recalled by Candela | Candela | Other | 26 states |
| Device | CLASS II | Canister Hfc-134a /, Alum Product Number recalled by Candela | Candela | Other | 26 states |
| Device | CLASS II | Laser GentleLase Pro, Powered Laser Surgical Instrument recalled | Candela | Other | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |