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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 2 of 2

Device	Model / Reference	Registries	Class	Status
Reprocessed Sealed Electrophysiology Diagnostic Catheters	K012678	FDA 510(k)	Class II	Active
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology	K190610	FDA 510(k)	U	Active
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)	K161086	FDA 510(k)	Class II	Active
Reprocessed Pulse Oximeter Sensors	K102560	FDA 510(k)	Class II	Active
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters	K161700	FDA 510(k)	Class II	Active
Reprocessed Vessel Sealer	K123096	FDA 510(k)	Class II	Active
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis	K182272	FDA 510(k)	U	Active
Reprocessed Harmonic Shear	K132566	FDA 510(k)	U	Active
Reprocessed Laser Probe	K012682	FDA 510(k)	Class II	Active
Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheter	K043513	FDA 510(k)	Class II	Active
Reprocessed Stone Retrieval Baskets	K012581	FDA 510(k)	Class II	Active
Reprocessed Harmonic	K012571	FDA 510(k)	U	Active
Reprocessed Harmonic Scalpel	K111794	FDA 510(k)	U	Active
Reprocessed Phaco Tips	K012579	FDA 510(k)	Class II	Active
Reprocessed External Fixation Device	K083636	FDA 510(k)	Class II	Active
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider	K143260	FDA 510(k)	Class II	Active
Reprocessed Autosuture Gia Endoscopic Staplers	K070930	FDA 510(k)	Class II	Active
Reprocessed Femoral Compression Device	K012574	FDA 510(k)	Class II	Active
Reprocessed Baloon Inflation Device	K053188	FDA 510(k)	Class II	Active
Reprocessed Pulse Oximeter Sensors	K012677	FDA 510(k)	Class II	Active
Reprocessed Closure System	K133414	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