https://plainrecords.com/brand/sterilmed/New recalls of Sterilmed from FDA, CPSC and NHTSA records.en-ushttps://plainrecords.com/recall/device/z-0573-2026/https://plainrecords.com/recall/device/z-0573-2026/Wed, 26 Nov 2025 00:00:00 +0000Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.https://plainrecords.com/recall/device/z-0090-2019/https://plainrecords.com/recall/device/z-0090-2019/Wed, 17 Oct 2018 00:00:00 +0000Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.https://plainrecords.com/recall/device/z-0213-2018/https://plainrecords.com/recall/device/z-0213-2018/Wed, 03 Jan 2018 00:00:00 +0000Inadequate seal due to lack of adhesive gluehttps://plainrecords.com/recall/device/z-2669-2017/https://plainrecords.com/recall/device/z-2669-2017/Wed, 12 Jul 2017 00:00:00 +0000Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.https://plainrecords.com/recall/device/z-1846-2016/https://plainrecords.com/recall/device/z-1846-2016/Wed, 08 Jun 2016 00:00:00 +0000Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.https://plainrecords.com/recall/device/z-0404-2016/https://plainrecords.com/recall/device/z-0404-2016/Wed, 16 Dec 2015 00:00:00 +0000Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.https://plainrecords.com/recall/device/z-2819-2015/https://plainrecords.com/recall/device/z-2819-2015/Wed, 07 Oct 2015 00:00:00 +0000Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.https://plainrecords.com/recall/device/z-0059-2015/https://plainrecords.com/recall/device/z-0059-2015/Wed, 15 Oct 2014 00:00:00 +0000Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is connehttps://plainrecords.com/recall/device/z-0546-2009/https://plainrecords.com/recall/device/z-0546-2009/Tue, 13 Jan 2009 00:00:00 +0000SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable