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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Instrumed International, Inc.
- 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
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.
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