Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Brand
Ambu Incorporated
Lot Codes / Batch Numbers
Catalog Number: A000137000, Lot Numbers: 000026, 000037, 000097, 010026, 010077, 020006, 020026, 030046, 040016, and 020095.
Products Sold
Catalog Number: A000137000, Lot Numbers: 000026, 000037, 000097, 010026, 010077, 020006, 020026, 030046, 040016, and 020095.
Ambu Incorporated is recalling Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manuf due to Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
Recommended Action
Per FDA guidance
Ambu notified consignees with a letter dated 08/21/07 and flagged as Trouble Shooting Guide. The letter advised that some valves do not hold the set PEEP level under certain conditions and consignees were further advised to consider the guideline as an addendum to existing directions for use. Consignees were instructed to return (to Ambu) for replacement the identified lots listed in the notification and confirm receipt of the advisory by e-m or fax. Ambu subsequently identified additional lots of valves and replacement valve parts for recall and notified all consignees by "Urgent Device Recall" letter dated 11/29/07. The letter advised healthcare practitioners of the impact on patient treatment that may result in less than effective treatment. Consignees were further advised to cease use of the device and return for replacement.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026