Auris Health Recalls Monarch Aspirating Biopsy Needles Due to Breakage Reports
Auris Health is recalling 158 Monarch Aspirating Biopsy Needles because of reports of needle breakage. The devices were distributed to 11 states.
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 is classified as FDA Class II and involves a risk-of-harm product (needle breakage) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without confirmed reported illness.
Plain-English summary
Auris Health Inc. is recalling 158 units of Monarch Aspirating Biopsy Needles (REF: MBR-000012) due to reports of needle breakage. The affected devices are prescription-only medical devices with UDI B634MBR0000120.
The recall covers specific lots including RS181129-1, RS181129-2, RS181210-1, RS181210-2, RS181210-3, RS181210-4, RS190117-1, RS190125-1, RS190211-1, RS190225-3, RS190308-1, and RS190319-1. These devices were distributed nationwide to the states of Connecticut, Florida, Michigan, Oklahoma, Tennessee, Mississippi, California, Minnesota, Ohio, Pennsylvania, and Illinois.
Healthcare providers and patients should stop using the affected Monarch Aspirating Biopsy Needles and contact Auris Health Inc. for further instructions or a return. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
- Manufacturer
- AURIS HEALTH INC
- Category
- Medical Device — Biopsy Needle
- Hazard
- Affected units
- 158
Distribution
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