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.
LivaNova USA is recalling 483 sterile perfusion packs because stopcocks may leak or become occluded during surgical procedures.
Stihler Electronic Gmbh is recalling PRISMAFLO II S blood return warmers because damage to the heating profile may cause low-level skin burns.
Fetzer Medical is recalling 2 units of Simpson OB Forceps because doctors reported being unable to pull the instruments apart.
Stryker is recalling 103 reprocessed diagnostic electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.
Kimberly-Clark is recalling U by Kotex Sleek Regular Tampons because they may come apart upon removal.
Arthrex is recalling Nano Corkscrew FT Suture Anchors because they may break during insertion. The recall covers 1,418 units distributed in the US and abroad.
Kimberly-Clark is recalling U by Kotex Sleek tampons because they may come apart upon removal. The recall covers 68,852,076 units distributed nationwide and in Canada.
Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Screw Caddies due to a potential for silicone shedding during cleaning and sterilization.
Smith & Nephew is recalling 72 units of the SL Plus Mia Double Offset Adapter because a pin may not be properly mounted and could disassemble.
Kimberly-Clark is recalling U by Kotex Sleek Regular Tampons because they may come apart upon removal.
Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Tray Bases because they may shed silicone during cleaning and sterilization.
Meridian Bioscience is recalling Premier Cryptococcal Antigen kits because an enzyme reagent may not maintain stability, potentially causing false negative results.
Waldemar Link is recalling 11 LINK STEM Reconstruction Prostheses because a manufacturing defect prevents the reaming guide from reaching the intended depth, which may lead to incorrect surgical positioning.
Bayer Medical Care is recalling MAVIG Portegra and Portegra2 Overhead Counterpoise Systems because the head mount knob may not be properly tightened, causing the injector head to become loose or fall.
Conformis, Inc. is recalling one iTotal Hip Replacement System because the reamer instruments used had a -1mm interference fit instead of the expected -2mm.
Kimberly-Clark is recalling U by Kotex Sleek Regular Tampons because the product may come apart upon removal.
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.
Waldemar Link is recalling 31 BiMobile UHMWPE Liners because internal labels may contain incorrect part numbers, risking errors in patient records.
Canadian Hospital Specialties is recalling 750 pediatric polyurethane feeding tubes because they may be packaged with a 5FR tube instead of the labeled 6.5FR size.
Waldemar Link is recalling 30 BiMobile UHMWPE Liners because internal labeling may contain incorrect part numbers, risking errors in patient records.
Arrow International Inc. is recalling specific lots of pediatric central venous catheters because the lidstock labels list incorrect priming volumes and flow rates.
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.
DeRoyal Industries is recalling 200 Enteral Safe Feed Tubes labeled as 6.5 FR but containing 5 FR tubes. The recall covers units distributed to Texas and Utah.
Ethicon is recalling 840 units of PERMA-HAND Silk Sutures because the product inside the packaging does not match the size or type indicated on the label.
Bound Tree Medical is recalling 84 Curaplex Epi Safe Administration and Training Kits because the epinephrine vials inside expired in December 2018, despite the outer label showing January 2020.
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