Data Foundry

Medical device recalls 2024

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D — Class I medical device recall Z-0637-2024

Ongoing recall by Percussionaire Corporation, reported 2024-01-24, distributed in AL, AR, CA, CT, FL, GA, IL, IN…. Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can

Recall numberZ-0637-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPercussionaire Corporation, Sandpoint, ID, United States
Recall initiated2023-12-12
Classified2024-01-17
Reported by FDA2024-01-24
DistributedAL, AR, CA, CT, FL, GA, IL, IN, KS, LA, MI, MN, MO, NC, NJ, OH, OR, TN, TX, UT, VA
Quantity2,145 units
UPC / GTIN / UDI-DI10849436000331
Lot numbersWO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930, WO06028
Model numbersA50605-D

Product

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0637-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.