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.
DePuy Orthopaedics is recalling 21 units of CORAIL COXA VARA High Offset Stem because the packages contained the wrong device model.
Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or type, potentially delaying patient treatment.
Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
B. Braun Medical is recalling Perifix FX Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.
Cook Inc. is recalling 85 Central Venous Catheter Sets because they may not fit over a guide wire, potentially causing procedure delays.
Synthes USA is recalling 5 units of Norian Drillable Inject because kit expiration dates do not align with the earliest component expiration dates.
Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems to update on-device labels and operator manuals, and to reduce the required separation distance from RF communication equipment.
Cook Inc. is recalling 25 Central Venous Catheter Trays because they may not fit over the guide wire, potentially causing procedure delays.
Aesculap Implant Systems LLC is recalling ELAN 4 Burr accessories because they were marketed without 510(k) premarket notification clearance.
OrthoPediatrics Corp is recalling 24 units of 7.0mm x 40mm pedicle screws because they were color anodized with the same color used for 5mm screws.
B. Braun Medical is recalling 11,920 units of Pencan Spinal Needle Trays because they contain loose polypropylene foreign matter above release specifications.
B. Braun Medical is recalling Perifix Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
B. Braun Medical is recalling PENCAN Spinal Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
Medtronic is voluntarily recalling specific Clip Gun Scalp Clip Kits and Applicators because they did not meet current packaging performance standards.
Sage Products is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
B. Braun Medical is recalling Spinal & Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
ConforMIS, Inc. is recalling two total knee replacement kits due to mislabeling. The affected units were distributed in California and Texas.
Keystone Dental Inc is recalling 20 units of Multi-Unit Abutments because they are unable to accept the final abutment screw.
Beckman Coulter is recalling specific lots of lyophilized chemistry calibrators because unpaired lots were distributed, which may cause erroneous calibration results.
Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.
Gibson Laboratories LLC is recalling Blastomyces dermatitidis Antiserum vials because the product was reporting false positive results.
Aesculap Implant Systems LLC is recalling ELAN 4 burr and blade accessories because they were marketed without 510(k) premarket notification clearance.
DePuy Orthopaedics is recalling 19 CORAIL High Offset Stem devices because they were packaged in a box labeled for a different size and type of stem.
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