Filter SafeStar 60A Plus MP05795Recalls & reported problems

Data updated Oct 16, 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.

3 other recalls cover devices cleared under the same FDA submission (K221836); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

Jun 16, 2025Open, Classified
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Z-2161-2025 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221836. One submission often covers many models, so check the product and lot details in each record.

Z-2159-2025 · Jun 16, 2025 · Open, Classified
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Z-2160-2025 · Jun 16, 2025 · Open, Classified
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Z-2158-2025 · Jun 16, 2025 · Open, Classified
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Device details

UDI-DI	`04048675665786`
Brand	Filter SafeStar 60A Plus
Model	MP05795
Company	Drägerwerk AG & Co. KGaA
Product code	CAH · Filter, Bacterial, Breathing-Circuit
Class	Class 2
FDA submission	K221836
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	Jan 23, 2026

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.

Other Filter, Bacterial, Breathing-Circuit devices

VOCSN V+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
1 recall570 reports
VOCSN V+Pro Emergency, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
558 reports
VOCSN V+O+C+S+N+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
3 recalls366 reports
VOCSN V+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
2 recalls2 deaths325 reports
VOCSN V+C+S+N+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
185 reports
GIBECK IPN043751
Teleflex Incorporated · Filter, bacterial, breathing-circuit
2 recalls7 reports
VOCSN VOCSN, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
1 death96 reports
VOCSN V+C+Pro, Japanese
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
1 recall33 reports

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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