Applied Medical Recalls Kii Shielded Bladed Access Systems Due to Blade Exposure Risk
Applied Medical is voluntarily recalling 72 units of Kii shielded bladed access systems because the blade may remain exposed after shield deployment.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could cause injury during surgery (blade exposure), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Applied Medical Resources Corp is conducting a voluntary recall of 72 units of its 12x150mm Kii shielded bladed access systems. The affected model number is CTB71, and the specific lot number is 1179107. These devices are used for general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or gain access through tissue planes.
The recall is being issued due to a potential for the blade to remain exposed after the shield is deployed. This defect presents a safety risk during surgical procedures. The affected products were distributed worldwide, including nationwide in the United States and in France.
Healthcare providers and consumers should cease using any affected product immediately. Users should check their inventory for model CTB71 with lot number 1179107 and stop using these devices if found.
The recalled product
- 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.
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 72
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 (1)
- Lot Number: 1179107
Distribution
Distributed nationwide across the United States.
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