Facility

PARKER LABORATORIES, INC.

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

Key facts

4recalls · worst Class II

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)	2212018
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	286 ELDRIDGE RD. FAIRFIELD, NJ, US 07004
Registration status	Active · expires 2026
Parent company	PARKER LABORATORIES, INC. (owner-operator 2212018)

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Product code NAE (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4022

Recalls & enforcement

Class IIOngoing2024-03-22
Product demonstrates low viscosity.
Class IIOngoing2024-01-22
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
Class IITerminated2017-04-13
There is a potential for the gel packets to have leaks in the packet seal.
Class IITerminated2014-08-06
Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.

FDA inspections (2)

VAI2023-05-23
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2018-03-20
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 PARKER LABORATORIES, 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. “PARKER LABORATORIES, INC. (FEI 2212018) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2212018-parker-laboratories-inc/

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