Facility

CYTRELLIS BIOSYSTEMS, INC.

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

Key facts

2recalls · 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)	3020704367
Establishment type	Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	34 Commerce Way Woburn, MA, US 01801
Registration status	Active · expires 2026
Parent company	Cytrellis Biosystems, Inc. (owner-operator 10082569)
Brand names	Ellacor(R) System with Micro-Coring(TM) Technology

Activity by year

Recalls (2)

Devices registered here (1)

Powered Microneedle Device
Product code QAI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4430

Recalls & enforcement

Class IIOngoing2023-06-23
Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture po…
Class IICompleted2023-04-07
Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring.

All facilities operated by Cytrellis Biosystems, 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. “CYTRELLIS BIOSYSTEMS, INC. (FEI 3020704367) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020704367-cytrellis-biosystems-inc/

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