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.
The Anspach Effort, Inc. is recalling 686 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
EXP Pharmaceutical Services Corp is recalling two sterile orthopedic saw blades because the company failed to register as a medical device establishment or establish its own quality system.
Hardy Diagnostics is recalling several microbiology media products, including BEA Broth with Vancomycin, because they lack FDA 510(k) clearance.
The Anspach Effort, Inc. is recalling 353 Fluted Ball dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
The Anspach Effort, Inc. is recalling 95 G1 dissection tools because the labeled shaft exposure may not be consistent with all listed attachments, potentially resulting in greater exposure than specified.
EXP Pharmaceutical Services Corp is recalling two units of tracheal stent sizing devices due to regulatory non-compliance regarding establishment registration and quality systems.
The Anspach Effort, Inc. is recalling 78 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
EXP Pharmaceutical Services Corp is recalling SECURESTRAP 5mm Absorbable Strap Fixation Devices because the company failed to register as a medical device establishment or maintain its own quality system.
The Anspach Effort, Inc. is recalling 92 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.
EXP Pharmaceutical Services Corp is recalling two units of PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.
EXP Pharmaceutical Services Corp is recalling four units of Trocar VersaPort Plus V2 devices because the company failed to register as a medical device establishment or maintain its own quality system.
The Anspach Effort, Inc. is recalling 65 Fluted Drum dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure.
Hardy Diagnostics is recalling specific lots of MacConkey Agar and other diagnostic media because they lack FDA 510(k) clearance.
EXP Pharmaceutical Services Corp is recalling Versaport Bladeless Trocar devices because the company failed to register as a medical device establishment or establish its own quality system.
The Anspach Effort, Inc. is recalling 80 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.
Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.
Synthes (USA) Products LLC is recalling 31 pre-bent maxillary plates due to potential incorrect laser etch denoting orientation.
EXP Pharmaceutical Services Corp is recalling Fiberwire Suture Scissors because the company failed to register as a medical device establishment or establish its own quality system.
The Anspach Effort, Inc. is recalling 189 Anspach 7MM Fluted Acorn dissection tools because the specified shaft exposure on the label may not be consistent with all listed attachments.
EXP Pharmaceutical Services Corp is recalling 12mm vascular transcatheter septal occluders because the company failed to register as a medical device establishment or establish a quality system.
The Anspach Effort, Inc. is recalling 110 fluted barrel dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
Ivoclar Vivadent is recalling IPS Empress Universal Glaze Spray because complaints indicated coarse particles in the glazed surface of dental restorations.
EXP Pharmaceutical Services Corp is recalling three units of implantable staple loading units because the company failed to register as a medical device establishment or maintain a quality system.
McKesson Technologies is recalling Paragon Laboratory Management software versions 12.1 and 12.1.1 because the Final Cumulative Report may display incorrect data when used with Microsoft SQL Server 2012.
The Anspach Effort, Inc. is recalling 118 G1 dissection tools because the specified shaft exposure on the label may not be consistent with all listed attachments.
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