Facility

TeleMed Systems

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

Key facts

1recalls · worst Class II

3inspections · 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)	1222168
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	44 Bearfoot Rd Ste 200 Northborough, MA, US 01532
Registration status	Active · expires 2026
Parent company	SHENT USA, INC. (owner-operator 10078923)
Brand names	DISPOSABLE RETRIEVAL BASKET

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Dislodger, Stone, Basket, Ureteral, Metal
Product code FFL (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.4680

Recalls & enforcement

Class IICompleted2021-01-12
Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat T…

FDA inspections (3)

VAI2026-07-02
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2023-06-09
Voluntary Action Indicated · Compliance: Devices
VAI2018-02-23
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.

All facilities operated by SHENT USA, 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. “TeleMed Systems (FEI 1222168) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1222168-telemed-systems/

Not open yet

Alerts for TeleMed Systems

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.