Percussionaire Corporation recalls Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line…
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of…
Read the official notice →- Date
- 2025-10-22
- Country
- United States
- Brand
- Percussionaire
- Product
- Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line…
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Percussionaire recalls
- 2026-10-07
USPercussionaire Corporation recalls Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents,…
FDA · DevicePercussionaire CorporationWorldwide - US Nationwide distribution including in the states of CA, PA, OK,…Official notice →- 2025-01-29
- US
Percussionaire Corporation recalls VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk…
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
FDA · DevicePercussionaire CorporationWorldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO,…Official notice → - 2024-11-06
- US
Percussionaire Corporation recalls Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway…
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a…
FDA · DevicePercussionaire CorporationU.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT,…Official notice → - 2024-10-09
- US
Percussionaire Corporation recalls Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
FDA · DevicePercussionaire CorporationUS: Nationwide OUS: Israel Japan Russia Switzerland Canada TurkeyOfficial notice → - 2024-01-24
- US
Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- US
Percussionaire Corporation recalls High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
FDA · DevicePercussionaire CorporationUS:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: NoneOfficial notice →
Other drugs & medical recalls in the United States
- 2025-10-22
- US
Boston Scientific Corporation recalls Model Number L211 PROPONENT DR SL MRI Pacemaker
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes…
- US
Olympus Corporation of the Americas recalls EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- US
Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W…
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
FDA · DeviceCook Medical IncorporatedDomestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC…Official notice → - US
Rising Pharma Holding, Inc. recalls Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings,…
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and…
- US
- US
Amerisource Health Services LLC recalls Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217,…
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity…