Low FDA (Devices)·Z-0533-2015·Announced 2014-12-17

Instrumed Recalls Endometrial Suction Curettes Due to Regulatory Non-Compliance

Instrumed International is withdrawing 26 endometrial suction curettes because the devices were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to regulatory non-compliance regarding pre-amendment status, with no reported injuries, illnesses, or specific physical hazards cited in the source text.

Plain-English summary

Instrumed International, Inc. is withdrawing 26 endometrial suction curettes from the market. These devices are used to remove material from the uterus and its mucosal lining by scraping and vacuum suction, typically for biopsies or menstrual extraction. The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

The reason for this withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the devices do not meet all FDA requirements to be marketed as "Pre-Amendment" devices. The affected products are sold under various trade names, including Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company.

Healthcare providers and facilities that have received these devices should stop using them and contact Instrumed International for instructions on how to return or dispose of the products. Consumers are advised to check with their healthcare providers if they have recently used these devices.

The recalled product

Product: An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include cathet
Manufacturer: Instrumed International, Inc.
Category: Medical Device — Surgical Instruments
Hazard: regulatory-non-compliance
Affected units: 26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

1) Instrumed Product Name: Novak Biopsy Suct Curette
x-del
2 mm
9"
Instrumed Product Number: 320-05942
Trade Name: Medline Industries
Medline Industries Product Name: Novak Biopsy Suct Curette
Medline Industries Item Number: MDG2480081
Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette
std
4 mm
Medline Industries Product Name: CURETTE
BIOSPY
NOVAK
4 MM
23 CM
Medline Industries Item Number: MDG2480091
Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette
Trade Name: Boss Instruments
Boss Instruments Product Name: Navak Biopsy SuctCurette

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 28 recalled by Instrumed International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

Same manufacturer · Instrumed International, Inc.

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Same hazard · regulatory non compliance