FDA Device recall Z-0644-2013
Laparoscope, general
- FDA Device
- Class II
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class II recall of Laparoscope, general by Applied Medical Resources, citing applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain ex….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0644-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-05 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Applied Medical Resources |
| Distribution | US |
Product
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Reason
Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.
Identifiers
| code_info | Lot Number: 1179107 |
|---|
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-0644-2013%22
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