Halyard Closed Suction System for Adults — Class II medical device recall Z-1427-2018
Terminated recall by Halyard Health, Inc, reported 2018-04-25, distributed nationwide. Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disc
| Recall number | Z-1427-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Halyard Health, Inc, Alpharetta, GA, United States |
| Recall initiated | 2018-02-07 |
| Classified | 2018-04-18 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2022-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BG, BO, BR, BS, CA, CL, CN, CO, CR, CZ, EC, ES, GB, GT, HK, HR, HU, IE, IL, IN, IT, JO, JP, KR, LB, MX, MY, NZ, PE, PH, QA, RO, SA, SE, SG, SI, SV, TH, ZA |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1427-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.