Facility

Remington Medical, S.A.

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

Key facts

4recalls · worst Class II

1inspections · worst NAI

—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)	3009265194
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Zona Franca Industrial de las Americas, Edificio B-11 Santo Domingo Este, DO 15001
Registration status	Active · expires 2026
Parent company	REMINGTON MEDICAL, INC. (owner-operator 9006473)

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Instruments, Surgical, Cardiovascular
Product code DWS (opens in a new tab) · Class I · Cardiovascular · 21 CFR 870.4500

Recalls & enforcement

Class IIOngoing2023-11-03
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
Class IITerminated2022-12-02
The stylet is longer than specified on the label
Class IITerminated2014-03-05
Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-).
Class IITerminated2012-08-29
Sterility of the product may be compromised.

FDA inspections (1)

NAI2018-08-30
No 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.

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. “Remington Medical, S.A. (FEI 3009265194) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009265194-remington-medical-s-a/

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