PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported April 25, 2018

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 DS

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

Recall #
Z-1428-2018
Affected scope
32,189 cases (20 units per case - 643,780 units) total
Initiated
February 7, 2018
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Halyard Health, Inc recalled Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adult… - a moderate-severity action.

Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adult… was recalled by Halyard Health, Inc in April 25, 2018. Reason: Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or dis…. Check the official notice for the remedy. Verify recall #Z-1428-2018 with the FDA Devices before acting.

The recall

Halyard Health, Inc issued this moderate-severity FDA Devices recall-Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or dis….

Moderate
severity level
Class II
classification
April 25, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1428-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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;

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1428-2018
Date reported April 25, 2018
Date initiated February 7, 2018
Recalling firm Halyard Health, Inc
Firm location Alpharetta, GA
Affected scope 32,189 cases (20 units per case - 643,780 units) total
Distribution 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, GUA…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1428-2018) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
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;. Recalled by Halyard Health, Inc. Units affected: 32,189 cases (20 units per case - 643,780 units) total.
Why was this product recalled? ▼
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1428-2018.
Where was the recalled product distributed? ▼
Distribution: 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..
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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This recall: FDA Devices, reported April 25, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026