Browse Device Recalls

32 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 32 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 32 FDA device recalls.

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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
Aug 22, 2023	therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Roto...	Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_...	Class II	Qiagen GmbH
May 19, 2023	QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not ...	Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis...	Class II	Qiagen GmbH
May 19, 2023	QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for...	Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis...	Class II	Qiagen GmbH
May 9, 2023	QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and ...	If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY00...	Class II	Qiagen GmbH
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
Aug 13, 2021	Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The ...	Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral lo...	Class II	Quidel Corporation
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
May 6, 2019	RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit ...	The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of...	Class II	Qiagen Sciences, Inc.
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
May 28, 2018	EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.	Underfilled reagent well that could lead to incorrect results	Class II	QIAGEN
May 18, 2018	AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and...	Potential for control line not appearing on the test strip	Class I	Qiagen Sciences, Inc.
Jul 22, 2017	QIAamp DSP Virus Kit Cat. No. 60704	Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in...	Class II	Qiagen, GmbH
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
Jan 30, 2013	QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: ...	CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.	Class II	QIAGEN Gaithersburg, Inc.
Jan 30, 2013	QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: ...	CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.	Class II	QIAGEN Gaithersburg, 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.