Facility

embecta Medical Devices (Suzhou) Co., Ltd.

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

Key facts

1recalls · 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)	3027605735
Establishment type	Manufacture Medical Device
Location	No.1 Liangpu Street Suzhou Jiangsu, CN --
Registration status	Active · expires 2026
Parent company	embecta Corp. (owner-operator 10084714)

Activity by year

Recalls (1)

Devices registered here (1)

Needle, Hypodermic, Single Lumen
Product code FMI (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5570

Recalls & enforcement

Class IIOngoing2024-06-18
BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.

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. “embecta Medical Devices (Suzhou) Co., Ltd. (FEI 3027605735) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027605735-embecta-medical-devices-suzhou-co-ltd/

Not open yet

Alerts for embecta Medical Devices (Suzhou) Co., Ltd.

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.