Facility

STERILMED, INC.

8 recall(s) on record — most severe on record: Class I.

Key facts

8recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011276773
Establishment type	Reprocess Single-Use Device; Develop Specifications But Do Not Manufacture At This Facility
Location	5010 Cheshire Pkwy N Ste 2 Plymouth, MN, US 55446
Registration status	Active · expires 2026
Parent company	STERILMED, INC. (owner-operator 9030419)
Brand names	Reprocessed External Fixation Device

Activity by year

Recalls (8)
Inspections (2)

Devices registered here (1)

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Product code KTT (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

Recalls & enforcement

Class IIOngoing2025-10-08
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.
Class IITerminated2018-09-17
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Class ITerminated2017-06-02
Inadequate seal due to lack of adhesive glue
Class IITerminated2017-05-08
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.
Class IITerminated2016-04-26
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Class IITerminated2015-11-13
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 h…
Class IITerminated2015-08-24
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.
Class IITerminated2014-09-24
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. Sterilme…

FDA inspections (2)

VAI2024-05-22
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2018-06-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by STERILMED, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “STERILMED, INC. (FEI 3011276773) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011276773-sterilmed-inc/

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