RegWardenFDA facility compliance records
Company

STERILMED, INC.

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

Recalls by year

FDA actions on record by year2014: 1 recalls; 2015: 2 recalls; 2016: 1 recalls; 2017: 2 recalls; 2018: 1 recalls; 2025: 1 recalls1’142’151’162’171’18’19’20’21’22’23’241’25’26
  • Recalls (8)

Registered facilities (1)

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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “STERILMED, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9030419-sterilmed-inc/

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