LCSU 4 — Class II medical device recall Z-0973-2018
Terminated recall by Laerdal Medical Corporation, reported 2018-03-21. A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused
| Recall number | Z-0973-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Laerdal Medical Corporation, Wappingers Falls, NY, United States |
| Recall initiated | 2017-08-31 |
| Classified | 2018-03-12 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-06-13 |
| Quantity | 204 |
Product
LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
Reason for recall
A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
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-0973-2018. 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.