Class I recallOngoing

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

FDA · FDA event 97166 · Posted Aug 13, 2025

Published Aug 13, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Potential for the manometer port being blocked rendering the manometer non-functional.

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

Ambu notified consignees on about 07/09/2025 via Urgent Field Safety Notice letter. Consignees were instructed to identify if there are any affected units on hand, notify Ambu of how many affected units are in possession, discard those affected units, and complete and return Appendix 1 of the Field Safety Notice. Additionally, consignees were instructed to notify all applicable personnel and notify customers if further distributed.

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

Affected products and models

This FDA record lists Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, by Ambu Inc..

Products affected by FDA event 97166
Model	Description	Lot / serial range	Manufactured	Status
Z-2181-2025	Z-2181-2025	1. Catalog Number: 523211000; UDI Number: 05707480152193; Lot Numbers: 1001113554, 1001118764. 2. Catalog Number: 523611051; UDI Number: 05707480149513; Lot Numbers: 2000015874. 3. Catalog Number: 523611057; UDI Number: 05707480038688; Lot Numbers: 2000015876. 4. Catalog Number: 524611000; UDI Number: 05707480152278; Lot Numbers: 1001110297. 5. Catalog Number: 524611001; UDI Number: 05707480149698; Lot Numbers: 2000015881. 6. Catalog Number: 524611011; UDI Number: 05707480149711; Lot Numbers: 2000015882. 7. Catalog Number: 524611031; UDI Number: 05707480149735; Lot Numbers: 2000015884, 2000015968. 8. Catalog Number: 524611047; UDI Number: 05707480149759; Lot Numbers: 2000016102. 9. Catalog Number: 524611051; UDI Number: 05707480154395; Lot Numbers: 2000015969, 2000016252. 10. Catalog Number: 530200016; UDI Number: 05707480149773; Lot Numbers: 2000014933, 2000015857. 11. Catalog Number: 530212000; UDI Number: 05707480152353; Lot Numbers: 1001113557. 12. Catalog Nu	Not provided in the normalized record	Ongoing

Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Units affected: See official FDA record
Category: Ventilators

Timeline

Jul 9, 2025
Recall initiated
Date recorded by the FDA.
Aug 13, 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: 97166
Published: Aug 13, 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

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Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

FDA · FDA event 97166 · Posted Aug 13, 2025

Published Aug 13, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, by Ambu Inc..

Products affected by FDA event 97166
Model	Description	Lot / serial range	Manufactured	Status
Z-2181-2025	Z-2181-2025	1. Catalog Number: 523211000; UDI Number: 05707480152193; Lot Numbers: 1001113554, 1001118764. 2. Catalog Number: 523611051; UDI Number: 05707480149513; Lot Numbers: 2000015874. 3. Catalog Number: 523611057; UDI Number: 05707480038688; Lot Numbers: 2000015876. 4. Catalog Number: 524611000; UDI Number: 05707480152278; Lot Numbers: 1001110297. 5. Catalog Number: 524611001; UDI Number: 05707480149698; Lot Numbers: 2000015881. 6. Catalog Number: 524611011; UDI Number: 05707480149711; Lot Numbers: 2000015882. 7. Catalog Number: 524611031; UDI Number: 05707480149735; Lot Numbers: 2000015884, 2000015968. 8. Catalog Number: 524611047; UDI Number: 05707480149759; Lot Numbers: 2000016102. 9. Catalog Number: 524611051; UDI Number: 05707480154395; Lot Numbers: 2000015969, 2000016252. 10. Catalog Number: 530200016; UDI Number: 05707480149773; Lot Numbers: 2000014933, 2000015857. 11. Catalog Number: 530212000; UDI Number: 05707480152353; Lot Numbers: 1001113557. 12. Catalog Nu	Not provided in the normalized record	Ongoing

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

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

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

Follow Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

Follow Ambu SPUR II Labeled as the following: 1 SPUR II Adult 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