Laparoscope — Class II medical device recall Z-0644-2013
Terminated recall by Applied Medical Resources Corp, reported 2013-01-16, distributed nationwide. Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed
| Recall number | Z-0644-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2013-01-07 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2013-01-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 72 units |
| Lot numbers | 1179107 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0644-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.