Facility

MEDIREHA GmbH

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

Key facts

7recalls · worst Class I

—inspections in our data

—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)	3003238222
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Am Laidhoelzle 2 Umkirch Baden-Wurttemberg, DE 79224
Registration status	Active · expires 2026
Parent company	DJO, LLC (owner-operator 9015378)
Brand names	Intelect RPW 2; Intelect RPW

Activity by year

Recalls (7)

Devices registered here (1)

Massager, Therapeutic, Electric
Product code ISA (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.5660

Recalls & enforcement

Class IIOngoing2026-03-19
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Class IIOngoing2025-09-25
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
Class IOngoing2021-09-07
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-…
Class IIOngoing2019-01-17
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Class IITerminated2018-06-25
The device accessories were not labeled with appropriate latex warning.
Class IITerminated2015-08-21
Overheating and burning of the wire insulation inside the applicator.
Class IITerminated2013-05-28
DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).

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. “MEDIREHA GmbH (FEI 3003238222) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003238222-medireha-gmbh/

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