FDA Device recall Z-0533-2015
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping an…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping an… by Instrumed International, citing the reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0533-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-08 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instrumed International |
| Distribution | US |
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 catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.
Reason
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Identifiers
| code_info | 1) Instrumed Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9"; Instrumed Product Number: 320-05942; Trade Name:…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 N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.