Z-1814-2025Class I

Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing...

Name: Z-1814-2025 Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing...
Creator: SunMed Holdings, LLC
Published: 2025-05-01
License: https://open.fda.gov/license/

Salter Labs / initiated 2025-05-01 / Open, Classified / root cause: manufacturing process

FDA source

SunMed Holdings, LLC began a recall of Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F on 2025-05-01. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1814-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-01
Posted: 2025-05-30
Recalling firm: Salter Labs
Product: Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 11,358
Distribution: US Nationwide distribution via Medline.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1814-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1814-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30

Product code BTM

K953546Class IIManual Pulmonary ResusicitatorMedical Marketing Concepts / cleared 1996-02-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)