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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.
Terumo Medical Corp is recalling 240 Angio-Seal Evolution Vascular Closure Devices because they were released before required validation was completed.
B. Braun Medical is recalling 26-Lead Transfer Sets for the APEX Compounding System because valves may be incorrectly oriented, posing a risk of unintended admixture.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The firm states the residue is biocompatible.
Trilliant Surgical Ltd. is voluntarily recalling 90 units of Ratcheting Cannulated Driver Handles that may fail to retain the mating adapter shaft.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging bags.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling 510 M/L Taper Hip Prostheses distributed to Japan due to potential black residue in the packaging.
FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter can damage implanted leads if over-tightened, requiring replacement.
St. Jude Medical is recalling 986 Confirm Rx Insertable Cardiac Monitors because exposure to sub-freezing temperatures caused a transient battery voltage drop, resulting in an incorrect low battery indicator display.
Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2 because a stability issue in the buffer prevents the chromogen from developing.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides due to a potential for imprecise results in quality control and patient samples.
St Jude Medical is recalling Merlin PCS Programmer Software to address an incorrect low battery indicator on Confirm Rx ICM devices caused by supply chain temperature exposure.
Implant Direct Sybron is recalling 60 REPLANT 5.0mmD Abutments because they are out of specification and cannot be properly fitted to implants.
Arrow International is recalling 1,200 multi-lumen central venous catheter sets due to increased resistance during insertion, which may cause procedural delays.
Trilliant Surgical Ltd. is voluntarily recalling 94 cannulated driver handles that may stick or fail to retain the mating adapter shaft.
GE Healthcare is recalling 69,231 CARESCAPE Monitor B650 units worldwide because they may simultaneously restart during prolonged network overloads.
Medtronic is recalling 239,859 MiniMed Paradigm Veo insulin pumps due to an error in the Arabic language translation of the Predictive Alerts setting screen.
Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because they were shipped with incorrect instructions for use.
Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because the products were shipped with incorrect instructions for use.
Philips is recalling 477 OmniDiagnost Classic X-ray systems because a broken tilt actuator could cause the table to rotate uncontrollably, posing a risk of injury.
Konica Minolta is recalling CS-7 medical devices because the Panasonic Toughbook laptops used in some configurations have a potential battery ignition risk.
Konica Minolta is recalling ImagePilot D9MA units because the Panasonic Toughbook laptops used in some configurations may experience battery ignition.
Intersurgical Inc is recalling 1,340 Flexible Smoothbore Breathing Circuits because the tubing may block the exhalation port during assembly, posing a serious health risk to patients.
Philips is recalling 508 OmniDiagnost-Eleva X-ray systems because a broken actuator fixation can cause the table to rotate uncontrollably, posing a risk of injury.
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