RecallRadar

FDA Device recall Z-1538-2024

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only

On 2024-04-24 the FDA classified a Class II recall of Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only by Masimo, citing their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1538-2024
ClassificationClass II
Statusongoing
Initiated2024-02-15
Published2024-04-24
Last updated2026-09-13 11:57 UTC
CompanyMasimo
DistributionUS

Product

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,

Reason

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Identifiers

code_info
UDI:(01)00843997000666/Serial Number: 6000063773 6000063918 6000064156 6000064251 6000064298 6000065602 6000066119 6000…UDI:(01)00843997000666/Serial Number: 6000063773 6000063918 6000064156 6000064251 6000064298 6000065602 6000066119 6000066282 6000066408 6000066411 6000066442 6000066476 6000066577 6000066623 6000066856 6000067119 6000067120 6000067122 6000067134 6000067140 6000067142 6000067145 6000067150 6000067151 6000067162 6000067163 6000067167 6000067168 6000067170 6000067173 6000067175 6000067176 6000067177 6000067178 6000067179 6000067180 6000067182 6000067183 6000067185 6000067186 6000067188 6000067192 6000067193 6000067194 6000067196 6000067198 6000067201 6000067202 6000067207 6000067211 6000067224 6000067225 6000067235 6000067241 6000067245 6000067246 6000067247 6000067252 6000067256 6000067269 6000067272 6000067278 6000067293 6000067300 6000067309 6000067311 6000067312 6000067314 6000067345 6000067356 6000067357 6000067360 6000067366 6000067367 6000067418 6000067443 6000067446 6000067472 6000067475 6000067482 6000067484 6000067486 6000067496 6000067515 6000067552 6000067563 6000067584 60000

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1538-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.