Facility

Devicor Medical Products de Mexico S de RL de CV

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

Key facts

5recalls · worst Class II

—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)	3008992312
Establishment type	Manufacture Medical Device
Location	Sor Juana Ines de la Cruz #20152 4-B Tijuana Baja California, MX 22440
Registration status	Active · expires 2026
Parent company	Devicor Medical Products, Inc. (owner-operator 10033297)
Brand names	HydroMark Breast Biopsy Site Marker

Activity by year

Recalls (5)

Devices registered here (1)

Marker, Radiographic, Implantable
Product code NEU (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4300

Recalls & enforcement

Class IIOngoing2026-04-24
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Class IITerminated2022-03-30
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Class IIITerminated2020-09-07
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Class IITerminated2017-02-28
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Class IITerminated2016-05-19
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

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. “Devicor Medical Products de Mexico S de RL de CV (FEI 3008992312) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008992312-devicor-medical-products-de-mexico-s-de-/

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