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.
DeRoyal Industries is recalling 40 units of STURDI STRAINER TRAY STANDARD procedure packs nationwide due to potentially compromised outer package seals that could affect sterility.
DeRoyal Industries is recalling 3 packs of Pelvic Exam Trays because the outer package seals may be open or compromised, potentially affecting the sterility of the medical procedure packs.
Siemens Aptio Automation Storage and Retrieval Module has a firmware error that may incorrectly associate test results to patient samples, potentially leading to incorrect patient results. Eighty-three units are affected worldwide.
TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.
Teleflex recalls the Pilling LOWSLEY PROSTATIC TRACTOR STR due to incomplete pre-cleaning instructions in the product manual. The issue affects 32 units distributed nationwide and internationally.
Korean-language instructions for Trilogy Evo ventilators contain a mistranslation where 'invasive' was incorrectly rendered as 'noninvasive.' This error could lead to improper device configuration by Korean-speaking users.
Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.
TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.
DeRoyal Industries is recalling 4,225 custom medical procedure packs nationwide because outer package seals may be open or compromised, potentially affecting sterility of the surgical materials inside.
Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.
TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.
The FDA has recalled BETTA LINK SR Knotless Implant Kits because the drill guides may bend during surgical procedures, potentially releasing metal shavings. This affects surgeons and patients undergoing orthopedic ligament and tendon repair procedures worldwide.
Full Vision Inc is recalling 1,416 TrackMaster GE T2100-ST2 220V treadmills worldwide due to a drive circuit board defect that can cause the treadmill to stop suddenly, reverse unexpectedly, or accelerate forward, posing a risk of falls or injury.
The BD Synapsys Informatics Solution may incorrectly associate patient demographic data under specific conditions when the system operates near capacity during rapid manual result processing.
GE HealthCare is recalling approximately 4,540 Giraffe OmniBed and Giraffe OmniBed Carestation neonatal warming devices worldwide due to potentially incorrect secondary latches on bedside panels.
Full Vision's TrackMaster treadmill can experience drive PCB malfunctions causing unexpected stopping, reversal, and acceleration. The malfunction affects 264 units distributed worldwide.
BD Pyxis CII Safe automated dispensing cabinets may leak excessive electrical current when connected to multi-socket power strips, risking electric shock and system downtime.
Drive board malfunction in TrackMaster TMX428 treadmills can cause unexpected belt reversal or acceleration, creating fall and impact injury risks. 376 units affected.
TEI Biosciences is recalling 4,159 units of PriMatrix Dermal Repair Scaffold nationwide due to possible out-of-specification endotoxin test results. Quality control issues during testing led to this recall.
TEI Biosciences recalls 199 units of Revize Collagen Matrix due to possible out-of-specification endotoxin test results from faulty testing procedures. The product is distributed nationwide.
T.A.G. MEDICAL PRODUCTS CORPORATION is recalling Betta Link LG Reusable ProngED Guides used in orthopedic surgery because the guides may bend when force is applied, creating metal shavings that could injure patients.
TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.
TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a surgical collagen matrix, due to possible out-of-specification endotoxin test results.
TELEFLEX LLC recalled the Pilling O'REILLY ESOPHAGEAL RETRACTOR (REF 381801A) due to incomplete pre-cleaning instructions in the product's Instructions for Use. The recall affects 365 units distributed nationwide and internationally.
Zimmer, Inc. is recalling NexGen Precoat Stemmed Tibial Plate Size 5 devices due to incorrect outer packaging labeling. Affected units were distributed internationally in India.
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