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 110 Anspach Fluted Barrel dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure.
The Anspach Effort, Inc. is recalling 69 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.
The Anspach Effort, Inc. is recalling 75 Anspach 7mm Extra Coarse Diamond Ball dissection tools because the specified shaft exposure may be inconsistent with the labeled attachments.
Siemens is recalling ACUSON S2000 and S3000 ultrasound systems with Virtual Touch IQ due to a potential measurement alignment error.
The Anspach Effort, Inc. is recalling 88 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.
EXP Pharmaceutical Services Corp is recalling 12mm Dilating Tip Trocars because the company failed to register as a medical device establishment or maintain a quality system.
EXP Pharmaceutical Services Corp is recalling 12 sterile dilating tip trocars because the company failed to register as a medical device establishment or maintain a quality system.
EXP Pharmaceutical Services Corp is recalling 12 Stryker Femoral Canal Tips because the company failed to register as a medical device establishment or maintain its own quality system.
The Anspach Effort, Inc. is recalling 227 Fluted Acorn dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.
EXP Pharmaceutical Services Corp is recalling 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 two units of specimen retriever bags because the company failed to register as a medical device establishment or establish its own quality system.
EXP Pharmaceutical Services Corp is recalling 10x40 Airway Stent Systems because the company failed to register as a medical device establishment or maintain its own quality system.
EXP Pharmaceutical Services Corp is recalling 3.5mm Threaded Cerclage Pins because the company failed to register as a medical device establishment or establish a quality system.
EXP Pharmaceutical Services Corp is recalling three Auto Suture Endo Universal devices because the company failed to register as a medical device establishment or establish its own quality system.
Hardy Diagnostics is recalling MDR Acinetobacter and other diagnostic media because they lack FDA 510(k) clearance.
EXP Pharmaceutical Services Corp is recalling six Stryker Round Fluted Bur devices due to the company's failure to register as a medical device establishment.
The Anspach Effort, Inc. is recalling 178 units of 3mm Fluted Ball dissection tools because the specified shaft exposure may be inconsistent with the product labeling.
EXP Pharmaceutical Services Corp is recalling seven sterile laparoscope pouches because the company failed to register as a medical device establishment or maintain a quality system.
EXP Pharmaceutical Services Corp is recalling 10MM Vascular Transcatheter Septal Occluders because the company failed to register as a medical device establishment or establish its own quality system.
EXP Pharmaceutical Services Corp is recalling GIA Auto Suture Loading Units because the company failed to register as a medical device establishment or establish a quality system.
EXP Pharmaceutical Services Corp is recalling three Angio-Seal VIP Platform vascular closure devices due to regulatory non-compliance regarding establishment registration and quality systems.
EXP Pharmaceutical Services Corp is recalling a medical device exchange product because the company failed to register as a medical device establishment or establish its own quality system.
EXP Pharmaceutical Services Corp is recalling two units of Endo Catch 10mm devices because the company failed to register as a medical device establishment or establish a quality system.
EXP Pharmaceutical Services Corp is recalling sterile suction coagulator devices because the company failed to register as a medical device establishment or establish a quality system.
The Anspach Effort, Inc. is recalling 178 G1 dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure than labeled.
Looking for a different category? Browse all recalls.