Facility

CUSTOMED, INC.

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

Key facts

4recalls · worst Class I

5inspections · 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)	2648727
Establishment type	Repack or Relabel Medical Device
Location	CALLE IGUALDAD No. 7 Fajardo, PR, US 00738
Registration status	Active · expires 2026
Parent company	CUSTOMED, INC. (owner-operator 9000786)
Brand names	customed

Activity by year

Recalls (4)
Inspections (5)

Devices registered here (1)

Tips And Pads, Cane, Crutch And Walker
Product code INP (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3790

Recalls & enforcement

Class IITerminated2016-01-07
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IITerminated2015-07-10
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class ITerminated2014-10-08
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class ITerminated2014-05-20
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

FDA inspections (5)

VAI2024-10-04
Voluntary Action Indicated · Compliance: Devices
NAI2023-04-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-09-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-09-21
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2016-08-31
Voluntary Action Indicated · Compliance: 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 CUSTOMED, 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. “CUSTOMED, INC. (FEI 2648727) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2648727-customed-inc/

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