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.
Remel Inc. is recalling a diagnostic test that may incorrectly report antibiotic susceptibility in certain Gram-negative bacteria. False results could lead to inappropriate antibiotic treatment.
Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.
Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.
Remel's Sensititre STP6F diagnostic plates may produce false susceptible results for Gram-negative bacteria when tested with certain antibiotics, potentially leading to inappropriate treatment decisions.
Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.
Remel Inc is recalling 588 units of the Sensititre Gram Negative IVD AST diagnostic plate due to false susceptible test results for certain bacteria when tested with specific antibiotics. The defect could lead to incorrect treatment decisions.
Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.
Dewei DNA/RNA Preservation Kits (catalog DW-80005-1B) were distributed in the U.S. without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.
Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.
Cardinal Health is recalling Dover urinary catheter trays due to potential blockage of the drainage bag inlet port, which may prevent urine drainage and increase the risk of urinary retention.
CareFusion bipolar forceps recalled nationwide due to incomplete Instructions for Use missing power supply interface and cleaning information. The missing content could affect proper device operation and maintenance.
CareFusion is recalling 1369 units of V. Mueller bipolar surgical forceps (Model F-1000) due to incomplete instructions for use. The provided instructions lack information about power supply interface and cleaning and maintenance procedures.
CareFusion bipolar forceps have incomplete Instructions for Use missing power supply interface and maintenance guidance. Users should obtain complete instructions from the manufacturer before use.
CareFusion recalls 142 units of bipolar surgical forceps due to incomplete Instructions for Use lacking power supply interface and maintenance guidance found in the manufacturer's version.
CareFusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing power supply interface and maintenance guidance.
Cardinal Health is recalling Dover closed urethral catheter trays due to potential occlusion of the drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.
Insulet is recalling Omnipod 5 Controllers where the charging port and cable may melt or deform from excessive heat, potentially causing minor burns if touched and preventing the device from charging.
Randox Laboratories recalls IgM and IgA immunoturbidimetric assay kits due to carryover contamination that can cause elevated test results when run immediately after Fructosamine tests on RX instruments.
Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.
Full Vision Inc. TrackMaster treadmills with specific serial numbers have a circuit defect that may prevent the magnetic safety tether from stopping the treadmill during a fall.
Full Vision Inc. is recalling TrackMaster treadmills due to a circuit defect in the safety tether. If the magnet detaches during a fall, the treadmill may fail to stop.
Looking for a different category? Browse all recalls.