Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury risks or hospitalization reports are rated as Severe (4).
Plain-English summary
Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets (1 X Diamond 1 X Bevel), code INTVM-DSSKBD. The recall involves specific lot numbers: 19102741, 200127, 2001246, and 2101242.
The FDA has classified this as a Class II recall because the products were labeled as sterile but may not have been sterilized. This defect poses a risk of infection if the devices are used in medical procedures.
The affected units were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky. Healthcare facilities and consumers who possess these specific lots should stop using the devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 625
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 (4)
- LOT: 19102741
- 200127
- 2001246
- 2101242
Distribution
Part of a larger recall action
This product is one of 19 recalled by BIOPSYBELL S.R.L. 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.
See all 19 products in this recall →Related recalls
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