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.
St. Jude Medical is recalling 17 Proclaim DRG Implantable Pulse Generators due to error messages during routine checks and transient overstimulation causing patient discomfort.
ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.
Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because their rotational locking mechanisms may fail to operate, preventing the table from changing between locked and unlocked states.
Deerfield Imaging is recalling 26 IMRIS ORT100 operating room tables because they may drift during use, potentially causing unintended movement.
Deerfield Imaging is recalling 17 IMRIS ORT200 operating room tables because they may drift during use, potentially causing unintended movement.
Cook Inc. is recalling specific lots of IVF embryo transfer sets and catheters because they were distributed without completed quality testing, posing a risk of nonviable gametes or embryos.
Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.
Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.
Becton Dickinson is recalling 1,976,000 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubes because increased residual blood was found on the top of the stopper well after venipuncture.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.
Zimmer Biomet is recalling the ACE Trochanteric Nail System because a device performance review failed clinical analysis for survivorship.
Stryker is recalling 504 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.
Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.
ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause device failure.
Stryker is voluntarily recalling 28 Thoracic Pedicle Feelers because machine settings caused material degradation, creating a risk that the instrument tip may break.
Ohmeda Medical is recalling 1,179 rotating IV poles because they may fall, posing a risk of injury to patients, bystanders, or operators.
Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.
Inova Diagnostics is recalling one QUANTA-Lyser 240 EIA instrument because a defective power supply may cause loss of protective grounding.
Cook Inc. is recalling specific lots of Norm-Ject Tuberkulin Syringes used for IVF embryo transfer because they were distributed without completed quality testing.
Zimmer Biomet is recalling AIM Tibial Nails because the surgical revision rate exceeded acceptance criteria in a clinical analysis.
Madison Polymeric Engineering is recalling 285 cases of the First Step Flexible Endoscope Bedside Pre-Clean Kit because affected lots may have exceeded microbial limits.
Konica Minolta is recalling 85 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.
Mesa Laboratories is recalling specific lots of ProSpore Biological Indicators because the concentration of bromocresol purple does not conform to specification.
Johnson & Johnson is recalling COACH Self-Adhering Sports Wraps because the label incorrectly states they are not made with natural rubber latex, though latex was used in early manufacturing.
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