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.
Zimmer Biomet is recalling nine Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.
Zimmer Biomet is recalling 15 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Zimmer Biomet is recalling 18 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Besmed Health Business Corporation is recalling Ambu Aura40 Standard reusable laryngeal masks because they are packaged in pouches marked as single-use.
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Terumo is recalling 152 Advanced Perfusion System 1 Electronic Patient Gas Systems because the service manual was not updated for software version 1.30.
Cypress Medical Products LLC is recalling 400 cases of McKesson Insulin Syringes because a small hole impedes liquid suction.
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
Zimmer Biomet is recalling 12 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 34 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 10 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Siemens Healthcare Diagnostics is recalling 69 kits of ADVIA Centaur CKMB Calibrator 2-pack Japan due to a potential bias identified compared to internal standards.
OriGen Biomedical is recalling 169 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.
Zimmer Biomet is recalling 22 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
The FDA is recalling 72 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, creating a potential contamination risk.
Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime software versions 1.13 and lower due to five identified behavioral issues affecting diagnostic testing.
Zimmer Biomet is recalling 44 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Life Technologies is recalling 240 units of Gibco DPBS due to defective bottle caps that compromise sterility.
Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CKMB Master Curve Material due to a potential bias identified when compared to internal standards.
Looking for a different category? Browse all recalls.