Class I recallOngoing

Adult Manual Resuscitator recall — FDA event 96801

FDA · FDA event 96801 · Posted May 30, 2025

Published May 30, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Update delayed: We have not successfully checked this official source since 2026-10-08 18:58:41 UTC. This page may not include the latest recall or safety information. Check the linked FDA source before making a health decision.

What happened

Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Recall initiated May 1, 2025. Customers instructed to immediately cease use of any affected product and quarantine all affected product. Customers were instructed to return or destroy affected product. AirLife will send new replacement product to customers once disposition is confirmed.
If you need replacement products to be sent to you urgently, please call AirLife directly on 1-800-433-2797 and the firm will make every effort to accommodate your needs.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Adult Manual Resuscitator by SunMed Holdings, LLC.

Products affected by FDA event 96801
Model	Description	Lot / serial range	Manufactured	Status
Z-1814-2025	Z-1814-2025	UDI-DI: EA: 10884389164822 CS: 40884389164823 Lots: 526782 526790 526796 526797 526798 526800 526802 526804 526805 526806 526807 526808 526809 526810 526814 526815 526816 526811 526817 526818	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution via Medline.
Units affected: See official FDA record
Category: Ventilators

Timeline

May 1, 2025
Recall initiated
Date recorded by the FDA.
May 30, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96801
Published: May 30, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Adult Manual Resuscitator recall — FDA event 96801

FDA · FDA event 96801 · Posted May 30, 2025

Published May 30, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists Adult Manual Resuscitator by SunMed Holdings, LLC.

Products affected by FDA event 96801
Model	Description	Lot / serial range	Manufactured	Status
Z-1814-2025	Z-1814-2025	UDI-DI: EA: 10884389164822 CS: 40884389164823 Lots: 526782 526790 526796 526797 526798 526800 526802 526804 526805 526806 526807 526808 526809 526810 526814 526815 526816 526811 526817 526818	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution via Medline.

Units affected

See official FDA record

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

Adult Manual Resuscitator recall — FDA event 96801

Follow Adult Manual Resuscitator

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Adult Manual Resuscitator recall — FDA event 96801

Follow Adult Manual Resuscitator

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline