Class II — Laerdal Medical (Suzhou) Co., Ltd.
| Recalling firm | LAERDAL MEDICAL A/S |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user. |
| Product | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. |
| Quantity | 5035 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| Initiated | 2020-12-18 |
| Classified | 2021-01-15 |
| Terminated | 2023-12-11 |
| Recall number | Z-0868-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Laerdal Medical (Suzhou) Co., Ltd. (Z-0868-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86702/
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