Laerdal Medical Corporation: Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)

Recall number

Z-1873-2017

Recalling firm

Laerdal Medical Corporation

Product

Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)

Status

Terminated

Initiated

2017-01-08

Posted

not on file

Terminated

2018-05-25

Reason

The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.

Root cause

Nonconforming Material/Component

Action

On January 8, 2017 Laerdal Medical distributed Urgent Device Recall Notification Letters to their customers thru Stericycle. The documents were dispatched via standard UPS ground delivery. Laerdal Medical has discovered that the LCSU4 may turn on by itself when connected to a power source and/or may not be able to be turned off with the on/off button without removing the battery or external power source. You can continue to use your suction units until your replacement arrives by following the steps: Exception: Some LCSU 4 units have a RW label on the bottom. These units have been reworked by Laerdal Medical and are not affected by this Field Safety Notice, even if they have manufacturing dates within the 20150501 to 20161028 range. **Check On/Off functionality** You can run a quick test to identify if the unit has failing On/Off functionality: Turn unit on; Turn unit off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component. The device should be taken out of service. The safety and effectiveness of the device is not affected by the failure of the On/Off button as long as it has power. Note that even if the unit passes this test, the problem may occur later. The actions below must be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit. **Actions to be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit** You can continue to use your LCSU 4 unit until you receive a replacement unit, but it is recommended to implement the following extra safety measures: Store the LCSU 4 unit without the battery connected so that it cannot turn on by itself. Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. All units with failing On/Off functionality should be removed from service. ** Actions to be taken if the On/Off functionality fails during clinical use** If the On/Off functionality fai

Quantity

4,377 units

Distribution

Nationwide

Lot, serial or model codes

Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.

510(k) numbers

not on file

PMA numbers

not on file

Product code

JCX

Firm FEI

2425852

Firm city

Wappingers Falls

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy