Manufacturer

Sterilmed, Inc.

9 recalls in our database name Sterilmed, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2025-11-26

Of the 9 recalls from Sterilmed, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

HighFDA (Devices)·Z-0574-2026·2025-11-26
Reprocessed imaging catheters recalled after exceeding validated reprocessing cycles
Sterilmed is recalling four reprocessed ACUSON AcuNav diagnostic ultrasound catheters because they were reprocessed beyond validated cycles.
Product
Brand 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 US
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0573-2026·2025-11-26
Non Siemens imaging catheters recalled after exceeding validated reprocessing cycles
Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.
Product
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
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0090-2019·2018-10-17
Sterilmed Recalls Reprocessed Agilis Steerable Introducers Due to Endotoxin Concerns
Sterilmed, Inc. is recalling 218 reprocessed Agilis Steerable Introducers because they may not meet endotoxin requirements. The devices were distributed in California, Colorado, Minnesota, and Washington.
Product
Reprocessed 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) la
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0213-2018·2018-01-03
Sterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers
Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.
Product
St. 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 sheath
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2669-2017·2017-07-12
Sterilmed Recalls Reprocessed EP Ablation Cables Due to Regulatory Status
Sterilmed is recalling 963 reprocessed EP ablation cables because they are Class III devices that lack required premarket approval.
Product
Electrophysiology 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 equi
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1846-2016·2016-06-08
Sterilmed Recalls Reprocessed Microline Scissor Tips Due to Manufacturing Defect
Sterilmed is recalling 11,326 reprocessed Microline Scissor Tips due to a potential manufacturing defect that could result in patient injury.
Product
Reprocessed 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, M
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-0404-2016·2015-12-16
Sterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns
Sterilmed is voluntarily recalling reprocessed tourniquet cuffs because the company cannot assure the sterility of all units in the affected lots.
Product
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2819-2015·2015-10-07
Sterilmed Recalls Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling
Sterilmed is recalling 43 reprocessed Zimmer tourniquet cuffs because they are labeled as single hose but are actually dual hose devices.
Product
Zimmer, 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0059-2015·2014-10-15
Sterilmed Recalls Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters
Sterilmed is recalling 22 reprocessed diagnostic ultrasound catheters because they were incorrectly processed. The affected units were distributed in Washington and California.
Product
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Category
Medical Device
Distribution
2 states