Aomori Olympus Vizishot Aspiration Needle Recall for Package Seal Defects
Aomori Olympus is recalling Vizishot 22G aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.
What this means for you
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 risk-of-harm product (infection from non-sterile equipment) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G (model no. NA-201SX-4022-A). These needles are used with ultrasound endoscopes for ultrasound-guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment may result in patients developing infections.
The recall affects 260,395 units distributed nationwide in the United States. Affected lots include codes 01K through 09K, 0XK, 92K through 9ZK, and 01V through 0XV. Users should stop using the affected needles and contact the manufacturer for further instructions.
The recalled product
- Product
- NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
- Manufacturer
- Aomori Olympus Co., Ltd.
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 (20)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 92K
- 93K
- 94K
- 95K
- 96K
- 97K
- 98K
- 99K
- 9XK
- 9YK
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 111 recalled by Aomori Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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