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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83839

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 10, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Candela Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.

Z-0206-2020
Recall number
Z-0206-2020
Initiated
September 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Candela Corporation
Quantity
in total 7,560 canisters (3240 additional as of 2/5/20)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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

device · product 2 of 4

Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.

Z-0207-2020
Recall number
Z-0207-2020
Initiated
September 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Candela Corporation
Quantity
386 cases ( 15 pack canister/ case) (216 additional cases as of 12/09/19)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Lot # 1904CC1598 1905CC0007 1905CC0178 1905CC0217 1906CC0196 1906CC0172 1907CC0008 1908CC0025 Additional lots added as of 12/9/2019: 1902CC0043 1902CC0143 1811CC0016 1812CC0074 1812CC0133 1901CC0087 1904CC0126 1802CC0092 1802CC0232 1803CC0169 1804CC0073 1805CC0058 1806CC0068 1807CC0009 1807CC0104 1808CC0112 1809CC0070 1810CC0015 1810CC0117 1907CC0187

Distribution pattern

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

device · product 3 of 4

Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.

Z-0208-2020
Recall number
Z-0208-2020
Initiated
September 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Candela Corporation
Quantity
in total 7,560 canisters (3240 additional as of 2/5/20)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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

device · product 4 of 4

Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.

Z-0209-2020
Recall number
Z-0209-2020
Initiated
September 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Candela Corporation
Quantity
in total 7,560 canisters (3240 additional as of 2/5/20)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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