CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Halyard Closed Suction System for Adults recalled by Halyard Health
Halyard Health is recalling Halyard Closed Suction System for Adults, distributed nationwide in the US. The recall was initiated on 7 Feb 2018 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-1429-2018
- FDA event ID
- 79531
- Recalling firm
- Halyard Health, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2018
- FDA classified
- 18 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 7 Feb 2018 | Recall initiated by company | |
| 18 Apr 2018 | Classified by FDA | +70 days |
| 25 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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;
Where it was distributed
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.
Questions about this recall
Is Halyard Closed Suction System for Adults recalled?
Yes. Halyard Health recalled Halyard Closed Suction System for Adults on 7 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1429-2018.
Why was it recalled?
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
Which lots are affected?
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;
Where was it sold?
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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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