Filter SafeStar 55 MP01790Recalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

May 16, 2022Class IOpen, Classified
Possible occlusion of filters due to manufacturing error.
Z-1211-2022 · Root cause: Process design · Recall details · FDA record ↗

Device details

UDI-DI	`04048675026785`
Brand	Filter SafeStar 55
Model	MP01790
Company	Drägerwerk AG & Co. KGaA
Product code	CAH · Filter, Bacterial, Breathing-Circuit
Class	Class 2
FDA submission	K072002
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Sep 22, 2020

Device type (GMDN): Microbial medical gas filter, single-use

A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

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All Filter, Bacterial, Breathing-Circuit devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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