Data Foundry

Medical device recalls 2015

Lifesaver Single Patient Use Manual Resuscitator Product Usage: The… — Class I medical device recall Z-1809-2015

Terminated recall by Teleflex Medical, reported 2015-07-01, distributed nationwide. The intake port may be blocked which can cause the bag to fail to fill.

Recall numberZ-1809-2015
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTeleflex Medical, Research Triangle Park, NC, United States
Recall initiated2015-05-14
Classified2015-06-24
Reported by FDA2015-07-01
Terminated2024-05-13
DistributedNationwide (US)
Countries outside the USAU, BS, CA, GT, MX
Quantity9,333 units
Lot numbers140317, 140504, 140507, 140508, 140514, 140515, 140517, 140520, 140608, 140614, 140616, 140617, 140621, 140623, 140630, 140714, 140719, 140806, 140809, 140812, 140819, 140823, 140923, 140924, 140929, 141013, 141103, 141110, 141115, 141117, 1412, 141201, 141214, 141224, 141227, 1419, 1420, 1421, 1424, 1425 and 19 more

Product

Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.

Reason for recall

The intake port may be blocked which can cause the bag to fail to fill.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1809-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.