Biopsy Needle Recall Due to Compromised Sterility Assurance
M.D.L. S.r.l. is recalling 2,750 Aspirated Cyto-Histological Biopsy needles nationwide due to compromised sterility assurance. Affected healthcare providers and patients should consult their healthcare provider for guidance.
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: This FDA Class II medical device recall involves compromised sterility assurance on biopsy needles, creating a risk-of-harm product. No illnesses, injuries, or hospitalizations are reported in the source, and the hazard is theoretical, placing it at score 3 per the rubric criteria for high-risk products without reported harm.
Plain-English summary
M.D.L. S.r.l. is recalling 2,750 Aspirated Cyto-Histological Biopsy needles in multiple models distributed nationwide. The recall was issued because sterility assurance may be compromised on the affected devices.
Compromised sterility on biopsy needles poses a potential infection risk when these devices are used for tissue sampling procedures. No illnesses or injuries have been reported to date.
The recall affects healthcare facilities and providers who have received or used these biopsy needles. The affected devices include multiple models (PB1810, PB1815, PB1820, PB1825, PB2010, PB2015, PB2020, PB2110, PB2115, PB2120, PB2215, PB2220, PB2225) with specific lot numbers identified in the FDA recall notice.
Healthcare providers should immediately cease use of affected devices and verify whether they have received any of the recalled biopsy needles. Patients who have undergone procedures using these needles should contact their healthcare provider for guidance.
The recalled product
- Product
- Aspirated Cyto-Histological Biopsy needle
- Manufacturer
- M.D.L. S.r.l.
- Hazard
- sterility-compromise
- infection-risk
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 (17)
- Model PB1810
- Lot 1617A Model PB1815
- Lots 5216C and 3620D Model PB1820
- Lot 5216C Model PB1825
- Lot 5216C Model PB2010
- Lot 1617A Model PB2015
- Lots 5216C
- 2618B
- and 3620D Model PB2020
- Lots 5216C and 1618A Model PB2110
- Lot 5216C Model PB2115
- Lot 5216C Model PB2120
- Lot 1617A Model PB2215
- Lot 5216C Model PB2220
- 1618A
- 3620D Model PB2225
- Lot 2518A
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03