CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Lcsu 4, Laerdal Compact Suction Unit The Lcsu recalled
Laerdal Medical is recalling Lcsu 4, Laerdal Compact Suction Unit The Lcsu 4 is a portable, electrically powered, distributed nationwide in the US. The recall was initiated on 31 Aug 2017 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-0973-2018
- FDA event ID
- 79190
- Recalling firm
- Laerdal Medical, Wappingers Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2017
- FDA classified
- 12 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2017 | Recall initiated by company | |
| 12 Mar 2018 | Classified by FDA | +193 days |
| 21 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationally
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Affected SNs between: 170401A0001 and 170401A0270
Where was it sold?
Nationally
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Laerdal Medical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Laerdal Compact Suction Unit 4 RTCA recalled by Laerdal Medical | Laerdal Medical | Other | Nationwide |
| Device | CLASS II | Laerdal Compact Suction Unit ¿ 4 under the following recalled | Laerdal Medical | Other | Nationwide |
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