FDAOctober 8, 2025device
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULT...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
sterilmed
UPCs
1088855100472599925322008779371572219499118277122199261048031222088111265842234882
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM...2025-10-08
- FDAReprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/...2018-09-17
- FDASt. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when i...2017-06-02
- FDAElectrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or ...2017-05-08
- FDAReprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.2016-04-26
- FDAZimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.2015-11-13
- FDAZimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack...2015-08-24
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