Browse Device Recalls
21 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 21 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 21 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 12, 2025 | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Refe... | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test r... | Class II | Qiagen Sciences LLC |
| Jun 3, 2024 | QIAcube Connect MDx - IVD Instrument designed to perform automated isolation ... | Heater shaker module does not perform heating if the temperature is set below 40¿C for static inc... | Class II | Qiagen Sciences LLC |
| Mar 4, 2024 | EZ2 Connect MDx-IVD Designed to perform automated isolation and purification ... | Insufficient welding leads to the heater cable becoming brittle and present with an error: ERRO... | Class II | Qiagen Sciences LLC |
| Apr 28, 2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PC... | Faulty cartridges in the lot could result in false test results. | Class II | Qiagen Sciences LLC |
| Jul 20, 2022 | therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 | Increased occurrence rate of false positive results, lead to a false positive sample result that... | Class II | Qiagen Sciences LLC |
| Jul 20, 2022 | therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 | Increased occurrence rate of false positive results, lead to a false positive sample result that... | Class II | Qiagen Sciences LLC |
| Jul 20, 2022 | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 | Increased occurrence rate of false positive results, lead to a false positive sample result that... | Class II | Qiagen Sciences LLC |
| Feb 25, 2022 | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the... | False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status result... | Class II | Qiagen Sciences LLC |
| Feb 25, 2022 | therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) | False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status result... | Class II | Qiagen Sciences LLC |
| Nov 21, 2021 | QIAcube Connect MDx, Model No. 9003070 | During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minima... | Class II | Qiagen Sciences LLC |
| Nov 8, 2021 | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69... | The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-... | Class II | Qiagen Sciences LLC |
| Jan 15, 2021 | SARS-CoV-2 Antigen Test | QIAGEN has become aware of the potential for false positive results to occur with some patient sa... | Class II | Qiagen Sciences LLC |
| Dec 11, 2020 | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identif... | Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactio... | Class II | Qiagen Sciences LLC |
| Jul 15, 2020 | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - P... | There is an increased rate of potential false positive results for the Influenza A (no subtype) t... | Class II | Qiagen Sciences LLC |
| Apr 8, 2020 | therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 | There is a risk for a false mutation positive result in rare cases resulting from a fluorescence ... | Class II | Qiagen Sciences LLC |
| Feb 21, 2020 | AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box)... | An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The c... | Class II | Qiagen Sciences LLC |
| Jan 28, 2020 | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed... | When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file r... | Class II | Qiagen Sciences LLC |
| Jul 2, 2019 | QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (T... | QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate I... | Class II | Qiagen Sciences LLC |
| Jun 5, 2019 | Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used ... | Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with ... | Class I | Qiagen Sciences LLC |
| Jul 23, 2018 | EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage... | An issue with the power branching printed circuit board (PCB) on the instrument that has the pote... | Class II | Qiagen Sciences LLC |
| Feb 2, 2016 | QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an i... | Potential for obtaining a false positive result due to the possibility of endotoxin presence. | Class II | Qiagen Sciences LLC |
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.