Transonic Systems Inc

Complete recall history across all FDA and CPSC categories — 13 total recalls

Transonic Systems Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (13)

FDA medical device enforcement actions by Transonic Systems Inc

Date Product Reason Class
Feb 15, 2018 Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT101... The sterility of the device cannot be assured. There is a potential for an in... Class II
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to m... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to meas... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to mea... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to ... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to m... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to ... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to mea... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transoni... Class II
Feb 17, 2015 Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemod... Customer unable to obtain measurements due to the device seeing no flow or ir... Class II
Mar 28, 2013 HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV... Transonic Systems Inc. have received complaints of blood leakage involving th... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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