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 catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, x-del, 2 mm, 9"; Medline Industries Item Number: MDG2480081; Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9", 23 CM; Medline Industries Item Number: MDG2480091; Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Boss Instruments; Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9"; Boss Instruments Item Number: 46-2974; Lot Number: 070512. 4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: 52-7050; Lot Numbers: 030412, 070512, 090212, 100213, 120412. 5) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: CareFusion; CareFusion Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; CareFusion Item Number: VM57-3085; Lot Numbers: 050313, 090212, 100213. 6) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: VM57-3085; Lot Number: 050313. 7) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Adler Instrument Company; Adler Instrument Company Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Adler Instrument Company Item Number: ADG1750; Lot Number: 100213.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Instrumed International, Inc.
- Reason for Recall:
- The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.
Product Codes/Lot Numbers:
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, x-del, 2 mm, 9"; Medline Industries Item Number: MDG2480081; Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9", 23 CM; Medline Industries Item Number: MDG2480091; Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Boss Instruments; Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9"; Boss Instruments Item Number: 46-2974; Lot Number: 070512. 4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: 52-7050; Lot Numbers: 030412, 070512, 090212, 100213, 120412. 5) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: CareFusion; CareFusion Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; CareFusion Item Number: VM57-3085; Lot Numbers: 050313, 090212, 100213. 6) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: VM57-3085; Lot Number: 050313. 7) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Adler Instrument Company; Adler Instrument Company Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Adler Instrument Company Item Number: ADG1750; Lot Number: 100213.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0533-2015
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