Facility

R82 A/S

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

Key facts

4recalls · worst Class II

1inspections · 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)	3001657382
Establishment type	Manufacture Medical Device
Location	PARALLELVEJ 3 GEDVED Midtjylland, DK DK-8751
Registration status	Active · expires 2026
Parent company	R82 A/S (owner-operator 9034750)
Brand names	Penguin; Orca

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Adaptor, Hygiene
Product code ILS (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.5050

Recalls & enforcement

Class IITerminated2021-12-08
The chrome surface of the push brace can crack during use, potentially cutting the user.
Class IITerminated2020-03-06
The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
Class IITerminated2019-03-28
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Class IIOngoing2017-06-30
Replacement campaign on all units that have a gas spring head in aluminum.

FDA inspections (1)

VAI2018-11-01
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 R82 A/S

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. “R82 A/S (FEI 3001657382) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001657382-r82-a-s/

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