The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2490-2021·Announced 2021-09-29

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.

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: 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.
Category
Medical Device — Surgical/Diagnostic Needle
Hazard
Affected units
2,750

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.

Part of a larger recall action

This product is one of 5 recalled by M.D.L. 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 5 products in this recall →

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