Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Qiagen is recalling QFT TB Antigen Tubes due to potential endotoxin presence that could cause false positive results in tuberculosis tests.
FDA is recalling Aplicare Castile Soap towelettes in Foley trays and specimen kits due to bacterial contamination.
FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.
FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.
The FDA is recalling Castile soap towelettes included in Foley trays and specimen kits due to bacterial contamination.
FDA is recalling Castile soap towelettes used in Foley trays and specimen kits due to bacterial contamination.
Ambu Inc. is recalling Aura Gain laryngeal masks because damage to the sterile barrier may compromise sterility, risking patient contamination.
Aplicare Castile Soap towelettes found in Foley trays and specimen kits are being recalled because they are contaminated with bacteria.
Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.
FDA is recalling Castile soap towelettes in Foley trays and midstream kits due to bacterial contamination.
QiG Group LLC is recalling 34 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close, preventing reprogramming and recharging.
FDA is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.
FDA is recalling 118,400 kits of Castile soap towelettes due to bacterial contamination. The products are used to clean the genital area.
FDA is recalling 10,000 units of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.
Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.
FDA is recalling 300 units of Foley catheter trays containing bacteria-contaminated Castile soap towelettes. The product was distributed in the US and Canada.
FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.
Castile soap towelettes used in Foley trays and specimen kits are recalled because they are contaminated with bacteria.
The FDA is recalling Aplicare Castile Soap towelettes included in Foley trays and midstream specimen kits due to bacterial contamination.
FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.
Castile soap towelettes in Foley trays and specimen kits are recalled because they are contaminated with bacteria.
FDA is recalling specific lots of Castile soap towelettes used in medical kits because they are contaminated with bacteria.
The Anspach Effort, Inc. is recalling Irrigation Clip 30 units assembled with incorrect smaller front clips. The affected clips were distributed in Pennsylvania, Minnesota, and Switzerland.
FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.
QiG Group LLC is recalling 31 Algovita External Pulse Generators because they may fail to connect to external devices, preventing reprogramming and recharging.
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