Sterilmed Recalls
9 recalls on record · October 15, 2014 to November 26, 2025 · Medical Devices
Recalls by year
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18
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 26, 2025Medical DevicesFDA
Sterilmed, Inc. recalls Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR
Hazard: Affected 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.
November 26, 2025Medical DevicesFDA
Sterilmed, Inc. recalls Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER AC
Hazard: Affected 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.
October 17, 2018Medical DevicesFDA
Sterilmed, Inc. recalls Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart.
Hazard: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
January 3, 2018Medical DevicesFDA
Sterilmed Inc recalls St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm,
Hazard: Inadequate seal due to lack of adhesive glue
July 12, 2017Medical DevicesFDA
Sterilmed Inc recalls Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and th
Hazard: Sterilmed 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.
June 8, 2016Medical DevicesFDA
STERILMED, INC. recalls Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive an
Hazard: Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
December 16, 2015Medical DevicesFDA
STERILMED, INC. recalls Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Hazard: Sterilmed, 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.
October 7, 2015Medical DevicesFDA
STERILMED, INC. recalls Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number
Hazard: Sterilmed, 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.
October 15, 2014Medical DevicesFDA
STERILMED, INC. recalls Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO
Hazard: Sterilmed, 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 conne