Laerdal LCSU 4 Suction Unit Recall: FDA Import Refusal
Laerdal Medical recalls LCSU 4 suction units that were refused by FDA due to missing approvals. Affected units have serial numbers between 170401A0001 and 170401A0270.
Recall notice
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.
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What happened, in plain English
Laerdal is recalling LCSU 4 portable suction units that were refused import into the U.S. by the FDA because they lacked necessary approvals. This recall affects specific serial numbers and does not involve a safety hazard in normal use. Read more at govinfonow.com/recall/73090-laerdal-lcsu-4-suction-unit-recall-fda-import-refusal.
Source Summary by GovInfoNow · govinfonow.com/recall/73090-laerdal-lcsu-4-suction-unit-recall-fda-import-refusal · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0973-2018
Cite this page
“Laerdal LCSU 4 Suction Unit Recall: FDA Import Refusal.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73090-laerdal-lcsu-4-suction-unit-recall-fda-import-refusal. Based on FDA recall #Z-0973-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0973-2018%22&limit=1).
Why it’s dangerous
The hazard described is that the units were refused import by the FDA due to missing approvals. There is no indication of a safety risk in normal use or a hazard that could cause injury.
Who’s affected
Medical professionals using portable suction units for patient care may own these units. The risk is limited to units that were refused import by the FDA and have specific serial numbers.
How to tell if you have this one
Check if your LCSU 4 suction unit has a serial number between 170401A0001 and 170401A0270. These units were refused import by the FDA for lacking necessary approvals.
- Brand
Laerdal- Category
Medical device
What to do — step by step
Check Serial Number
Verify your LCSU 4 unit's serial number falls between 170401A0001 and 170401A0270.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this unit?
Check if your serial number is in the range 170401A0001 to 170401A0270. If so, you may not need to take action as the units were not approved for U.S. use.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0973-2018 (August 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0973-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.