Laerdal Medical Corporation LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.
Brand
Laerdal Medical Corporation
Lot Codes / Batch Numbers
pediatric and preterm size LSR: 0403, 0703, 0803, 0903, 1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803, 1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103, 3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303, 4403, 4503, 4603, 4703, 4803
Products Sold
All product shipped after 1/29/2003 is affected. The following lot numbers are the lot numbers for adult, pediatric and preterm size LSR: 0403, 0703, 0803, 0903, 1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803, 1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103, 3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE: customers were NOT provided with lot numbers. They were instructed to visually examine the Intake/Reservoir valve in order to determine if they have affected product.
Laerdal Medical Corporation is recalling LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part No due to Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
Recommended Action
Per FDA guidance
Letters issued on 1/14/2004. The recall involves the replacement of the Inner Part of the Intake/Reservoir Valve, which is part of the Laerdal Silicone Resuscitator. Recall is to the user level.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026