Facility

AMERICAN SURGICAL COMPANY, LLC

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

Key facts

2recalls · 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)	1221144
Establishment type	Manufacture Medical Device
Location	100 Cummings Center, Suites 151-G, 144-F, and 250-G Beverly, MA, US 01915
Registration status	Active · expires 2026
Parent company	American Surgical Company, LLC (owner-operator 10030544)
Brand names	Telfa Sponges

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Neurosurgical Paddie
Product code HBA (opens in a new tab) · Class II · Neurology · 21 CFR 882.4700

Recalls & enforcement

Class IIOngoing2024-09-18
Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
Class IITerminated2016-03-31
Product packaging defective compromising sterility

FDA inspections (1)

NAI2017-01-26
No Action Indicated · Compliance: Devices; 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 American Surgical Company, LLC

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. “AMERICAN SURGICAL COMPANY, LLC (FEI 1221144) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1221144-american-surgical-company-llc/

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