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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 180 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 176 D&C Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 40 Urology Packs (Catalog 900-1738) due to compromised sterility and inadequate storage conditions that may result in patient infection.
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 236 units of Femoral Angiography Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 48 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling Wound Closure Tray I units because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Customed, Inc. is recalling 170 units of Gown Surg Fully Impervious Large due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 1,152 Laparoscopy Packs (Catalog 900-028) because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 36 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 195 Urology Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 75 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 400 Laparotomy Pack III units due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 108 Open Heart Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 550 O.R. Towels (Catalog 900-629) because significant sterility compromises and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 240 units of Laparoscopy and Pack (catalog #900-2483) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 36 orthopedic trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 200 Arthroscopy Packs (catalog #900-2473) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 176 O.B. Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 1,152 Angiodrape Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling six ACDF Packs (catalog #900-2917) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 132 Neuro Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 60 Hair Restoration Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 35 Endovenous Custom Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
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