Facility

NORTH COAST MEDICAL, INC.

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

Key facts

2recalls · worst Class I

2inspections · 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)	1000124207
Establishment type	Manufacture Medical Device
Location	135 E Main Ave Ste. 110 Morgan Hill, CA, US 95037
Registration status	Active · expires 2026
Parent company	NORTH COAST MEDICAL, INC. (owner-operator 9000531)
Brand names	Norco Pill Splitter; Norco Pill Crusher; Pill Pal

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Pill Crusher/Cutter
Product code OHY (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6430

Recalls & enforcement

Class IIOngoing2023-08-18
The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
Class IOngoing2021-08-27
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-…

FDA inspections (2)

VAI2024-08-02
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2023-08-28
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 NORTH COAST MEDICAL, 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. “NORTH COAST MEDICAL, INC. (FEI 1000124207) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000124207-north-coast-medical-inc/

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