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…
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Percussionaire
- Product
- Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway…
- Classification
- Class I
- Units
- U.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2025-10-22
- US
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…
FDA · DevicePercussionaire CorporationWorldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada,…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 → - 2024-10-09
- 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
- 2024-11-06
- US
Olympus Corporation of the Americas recalls Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
- US
Baxter Healthcare Corporation recalls a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208,…
The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide. There was government and military…Official notice → - US
Smiths Medical ASD Inc. recalls CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory…
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery…
- US
DATEX--OHMEDA, INC. recalls GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3)…
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week.…
- US
Maquet Cardiovascular, LLC recalls VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution. US Nationwide. Brazil, China, and Hong Kong.Official notice → - US
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15,…
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.