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.
Customed, Inc. is recalling 270 units of Shoulder Arthroscopy Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Customed, Inc. is recalling 680 General Minor Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 120 Arthoscopy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 36 breast packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Utility Drape End Products due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Premium Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Customed, Inc. is recalling 1,140 cataract packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling 840 Major Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 354 Pery GYN Surgical Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 71 Open Heart Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 240 impervious gowns due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 335 Premium OB Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Customed, Inc. is recalling 654 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 122 C-Section Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Management Tray III units because compromised sterility and manufacturing deficiencies may result in patient infection.
Bard Access Systems is recalling non-sterile GuardIVa Antimicrobial Hemostatic IV Dressing units that could potentially be used clinically.
Zimmer CAS is recalling 15 PSI Knee System units due to a design flaw that could lead to misalignment during surgery.
Aircraft Medical Limited is recalling McGrath MAC2 Video Laryngoscope Blades because the retaining clip may be difficult to engage, increasing the risk of the blade disconnecting during intubation.
Teleflex Medical is recalling Aquapak Nebulizer Adaptors because packaging seals may be open or weak, potentially compromising the sterility of the devices.
Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.
Amerx Health Care Corp. is recalling Amerigel Hydrogel Wound Dressing units due to a formulation deviation. The recall covers 340,896 units distributed nationwide and internationally.
Looking for a different category? Browse all recalls.