Facility

GENTELL

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

Key facts

2recalls · 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)	1000522686
Establishment type	Repack or Relabel Medical Device
Location	180 Rittenhouse Circle Bristol, PA, US 19007
Registration status	Active · expires 2026
Parent company	GENTELL (owner-operator 10026501)
Brand names	MM0012 Gentell Manuka Honey Non-Adherent Wrap 4 x 48 (10 x 122cm) (formerly MANUKAtex 4 x 48 (10 x 122cm)); MM0010 Gentell Manuka Honey Non-Adherent Dressing 4 x 5 (10 x 12.5cm) (formerly MANUKAtex 4 x 5 (10 x 12.5cm)); MM0011 Gentell Manuka Honey Non-Adherent Dressing 4 x 8 (10 x 20cm) (formerly MANUKAtex 4 x 8 (10 x 20cm))

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Dressing, Wound, Drug
Product code FRO (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IIOngoing2020-03-26
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class IIOngoing2020-02-27
During an FDA audit, it was discovered that the product was not properly registered with FDA.

FDA inspections (2)

NAI2019-12-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-12-13
Voluntary Action Indicated · Compliance: 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.

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. “GENTELL (FEI 1000522686) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000522686-gentell/

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