Browse Device Recalls
13 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 13 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 13 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 increased risk of infe... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to ... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to ... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| 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. Transonic received several c... | Class II | Transonic Systems Inc |
| 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 irrelevant flow condit... | Class II | Transonic Systems Inc |
| 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 the AV Loop Kit. | Class II | Transonic Systems Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.