Facility

REBISCAN, INC.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3014522421
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	100 Cambridge Street Boston, MA, US 02114
Registration status	Active · expires 2026
Parent company	Rebiscan, Inc. (owner-operator 10057507)
Brand names	PVS; blinq.

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Strabismus Detection Device
Product code PMW (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.1342

Recalls & enforcement

Class IIOngoing2022-10-03
Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the charge, could vent and possibly catch fire

FDA inspections (1)

NAI2019-10-31
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices

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 Rebiscan, 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. “REBISCAN, INC. (FEI 3014522421) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014522421-rebiscan-inc/

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