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Sterilmed, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 5010 Cheshire Pkwy N Ste 2, Plymouth, MN, 55446
Website: its.jnj.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(888)541-0078
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011276773
DUNS Number: 175899459

Catalogue (71)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Ace + 7	HARH23R	FDA UDI	U	Unknown
Reprocessed DECANAV EP Catheter, D Curve	RR7D282CT	FDA UDI	Class II	Active
Ace + 7	HARH36R	FDA UDI	U	Unknown
Ace + 7	HARH45R	FDA UDI	U	Unknown
Reprocessed DECANAV EP Catheter, F Curve	RR7F282CT	FDA UDI	Class II	Active
Ace+	HAR23R	FDA UDI	Class II	Unknown
Ace+	HAR36R	FDA UDI	Class II	Unknown
Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter	K240826	FDA 510(k)	Class II	Active
Reprocessed External Fixation Device	K081586	FDA 510(k)	Class II	Active
Reprocessed Vessel Sealer	K152134	FDA 510(k)	Class II	Active
Modification To: Reprocessed Oximax Pulse Oximeter Sensors	K041127	FDA 510(k)	Class II	Active
Reprocessed Surgical Electric Instrument	K120040	FDA 510(k)	Class II	Active
Sterilmed Intermittent Compression System, Garment Models 400 Series	K003857	FDA 510(k)	Class II	Active
Reprocessed Scissor Tips	K073613	FDA 510(k)	Class II	Active
Reprocessed Harmonic Scalpel	K083060	FDA 510(k)	U	Active
Reprocessed Pulse Oximeter Sensors	K092368	FDA 510(k)	Class II	Active
Reprocessed Guidewires	K012556	FDA 510(k)	Class II	Active
Reprocessed External Fixation Accessories	K081342	FDA 510(k)	Class II	Active
Reprocessed Electrophysiology Diagnostic Catheters	K012523	FDA 510(k)	Class II	Active
Reprocessed Pins	K100707	FDA 510(k)	Class II	Active
Sterilemed Reprocessed Ivus Imaging Catheter	K043453	FDA 510(k)	Class II	Active
Reprocessed Endoscopic Electrodes	K012685	FDA 510(k)	Class II	Active
Reprocessed Hot Biopsy Forceps	K050136	FDA 510(k)	Class II	Active
Reprocessed ViewFlex™ Xtra ICE Catheter	K190478	FDA 510(k)	Class II	Active
Reprocessed Ent Shavers	K081814	FDA 510(k)	Class II	Active
Reprocessed Electrophysiology Diagnostic Catheters	K150357	FDA 510(k)	Class II	Active
Reprocessed Imaging Catheters	K012537	FDA 510(k)	Class II	Active
Reprocessed Electrophysiology Diagnostic Catheters	K092158	FDA 510(k)	Class II	Active
Reprocessed Cold Biopsy Forceps	K042648	FDA 510(k)	Class I	Active
Reprocessed Endoscopic Trocars	K121240	FDA 510(k)	Class II	Active
Reprocessed Endoscopic Trocar	K012578	FDA 510(k)	Class II	Active
Sterilmed Reprocessed Compression Sleeves	K012597	FDA 510(k)	Class II	Active
Reprocessed Cordless Ultrasonic Dissection Device	K143562	FDA 510(k)	U	Active
Reprocessed Laparoscopic Electric Instuments	K012598	FDA 510(k)	Class II	Active
Reprocessed Steerable Introducer	K152090	FDA 510(k)	Class II	Active
Reprocessed Electrophysiology Diagnostic Catheters	K121158	FDA 510(k)	Class II	Active
Reprocessed Harmonic Scalpels	K050343	FDA 510(k)	U	Active
Reprocessed Deflectable Electrophysiology Diagnostic Catheters	K051220	FDA 510(k)	Class II	Active
Reprocessed Ethicon Ets Endoscopic Linear Cutters	K070859	FDA 510(k)	Class II	Active
Reprocessed Rf Arthroscopy Probes	K012679	FDA 510(k)	Class II	Active
Reprocessed 3d Diagnostic Ultrasound Catheter	K110076	FDA 510(k)	Class II	Active
Reprocessed Powered Arthroscopic Accessories	K012536	FDA 510(k)	Class II	Active
Reprocessed Electrophysiology Diagnostic Catheters	K101789	FDA 510(k)	Class II	Active
Reprocessed Femoral Compression Device	K120204	FDA 510(k)	Class II	Active
Reprocessed Endoscopic Trocar	K043592	FDA 510(k)	Class II	Active
Reprocessed Electrosurgical Electrode	K012684	FDA 510(k)	Class II	Active
Reprocessed Endoscopic Trocars	K111002	FDA 510(k)	Class II	Active
Reprocessed Heart Stabilizers And Positioners	K063844	FDA 510(k)	Class I	Active
Reprocessed Endoscopic Trocar	K052299	FDA 510(k)	Class II	Active
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter	K153006	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (41)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 8, 2025	Z-0574-2026	—	open, classified	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.
Oct 8, 2025	Z-0573-2026	—	open, classified	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.
Sep 17, 2018	Z-0090-2019	—	terminated	Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Jun 2, 2017	Z-0213-2018	—	terminated	Inadequate seal due to lack of adhesive glue
May 8, 2017	Z-2669-2017	—	terminated	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.
Apr 26, 2016	Z-1846-2016	—	terminated	Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Nov 13, 2015	Z-0404-2016	—	terminated	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.
Aug 24, 2015	Z-2819-2015	—	terminated	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.
Sep 24, 2014	Z-0059-2015	—	terminated	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
Aug 8, 2008	Z-0547-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0558-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0557-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0569-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0560-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0566-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0546-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0562-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0576-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0561-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0575-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0570-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0549-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0568-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0577-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0565-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0554-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0548-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0563-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0552-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0559-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0573-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0574-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0551-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0572-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0564-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0571-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0567-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0556-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0550-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0555-2009	—	terminated	SteriMed, 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
Aug 8, 2008	Z-0553-2009	—	terminated	SteriMed, 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