Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79531

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Halyard Health, Inc

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

3 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 3

Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CARE DSE TRACH; i. HALYARD* 14FR DSE 12IN/30.5CM; j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); r. HALYARD* 16FR TRACH CARE DSE ENDO; s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO

Z-1427-2018
Recall number
Z-1427-2018
Initiated
February 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
32,189 cases (20 units per case - 643,780 units) total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Code information

Product Description, (Product code): a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE), (2160); b. HALYARD* 12 FR TRACH CARE DSE ENDO, (2160-5); c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE), (21603); d. HALYARD* 12FR TRACH CARE DSE TRACH, (21603-5); e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN), (22108130, 2210, 22106, 22107, 22108, 22108147, 8224); f. HALYARD* 14FR TRACH CARE DSE ENDO, (2210-5); g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN), (22103, 221037, 221038, 8223, 221036); h. HALYARD* 14FR TRACH CARE DSE TRACH, (22103-5); i. HALYARD* 14FR DSE 12IN/30.5CM, (221036-5); j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH, (2210386-5); k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO, (22106-5); l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO, (221069-5); m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO, (22107-5); n. HALYARD* 14FR TRACH CARE DSE MDI ENDO, (22108-5); o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN), (22108148, 22109); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO, (22109-5); q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE), (2260, 22606); r. HALYARD* 16FR TRACH CARE DSE ENDO, (2260-5); s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO, (22606-5)

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.

device · product 2 of 3

Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; n. HALYARD* 72 DSE TRACH CARE 12FR; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

Z-1428-2018
Recall number
Z-1428-2018
Initiated
February 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
32,189 cases (20 units per case - 643,780 units) total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Code information

Product Description, Product code: a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN), 227; b. HALYARD* TRACH CARE-72 DSE ENDO 14FR, 227-5; c. HALYARD* TRACH CARE-72 WET PAK* 14FR, 22701356-5; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR, 2270156-5; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN), 22703; f. HALYARD* TRACH CARE-72 DSE TRACH 14FR, 22703-5; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR, 227036-5; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR, 227101-5; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK), 2271013; j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183; m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5; n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418; p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183; r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5; u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147; w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716; x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603; z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161; ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR, ag. 2271618-5; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR, 22716183-5; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR, 22716186-5; ai. HALYARD* TRACH CARE-72 DSE 16FR, 227161863-5; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR, 227166-5; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 2276; al. HALYARD* TURBO-CLEANING 14FR DSE Endo, 2276-5;

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.

device · product 3 of 3

Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

Z-1429-2018
Recall number
Z-1429-2018
Initiated
February 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
32,189 cases (20 units per case - 643,780 units) total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Code information

Product Description, Product code: a. HALYARD* MULTI-PORT, DSY, ENDO 10FR, 24010-5; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR, 240121-5; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR, 240128-5; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR, 24014-5; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR, 240143-5; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR, 2401436-5; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR, 2401438-5; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR, 240146-5; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR, 240146-5N; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR, 240148-5; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR, 240168-5; j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183; m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5; n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418; p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183; r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5; u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147; w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716; x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603; z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161; ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR, ag. 2271618-5; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR, 22716183-5; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR, 22716186-5; ai. HALYARD* TRACH CARE-72 DSE 16FR, 227161863-5; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR, 227166-5; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 2276; al. HALYARD* TURBO-CLEANING 14FR DSE Endo, 2276-5;

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.